Wednesday, August 31, 2016

Pharma Reviews: Pharma headwinds here to stay, tread with caution

MUMBAI: Financial year 2015-16 was one of the most volatile years for Indian pharma companies as they withstood increased regulatory clamps and ...
Read more: Pharma headwinds here to stay, tread with caution

Pharma Reviews: Listed pharma companies records robust Q1FY17 shrugging off uncertainties

Listed pharma companies records robust Q1FY17 shrugging off ... The Indian pharmaceutical market (IPM) grew by 9.5% to Rs 9125 crore in July 20 ...
Read more: Listed pharma companies records robust Q1FY17 shrugging off uncertainties

Pharma Reviews: Outwards to Africa

In 2014 India exported medicines worth $3.5 billion to Africa and the foreign direct investment (FDI) by Indian pharmaceutical companies in Africa was ...
Read more: Outwards to Africa

Pharma Reviews: PIL against Indian stroke drug motivated: Gennova to HC

New Delhi:- An Indian pharma company Gennova Biopharmaceuticals today claimed in Delhi High Court that the plea seeking to stop them from ...
Read more: PIL against Indian stroke drug motivated: Gennova to HC

US FDA News: Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring New Boxed Warnings About Serious Risks and Death

Combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system has resulted in serious side effects, including slowed or difficult breathing and deaths.
Read more: Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring New Boxed Warnings About Serious Risks and Death

US FDA News: FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use

FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use
Read more: FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use

Pharma Reviews: Pharma Industry Growth To Remain Moderate: Icra

"Indian pharmaceutical companies have registered strong growth over the last decade, driven mainly by American market with CAGR of revenue ...
Read more: Pharma Industry Growth To Remain Moderate: Icra

Pharma Reviews: PIL against Indian stroke drug motivated: Gennova to HC

An Indian pharma company Gennova Biopharmaceuticals today claimed in DelhiHigh Courtthat the plea seeking to stop them from launching a drug ...
Read more: PIL against Indian stroke drug motivated: Gennova to HC

Pharma Reviews: Nilesh Shah's 3-formula strategy to pick winning stocks

A: If you are taking a three year view according to me pharma sector provides a great opportunity. Most of the Indian pharma companies are today ...
Read more: Nilesh Shah's 3-formula strategy to pick winning stocks

Tuesday, August 30, 2016

Pharma Reviews: India will be world power in pharma, says Jhunjhunwala; is it time to buy?

He does not expect the definition of 'Big 3' in the pharma sector to change as cash flows give them the ability to invest further. Indian pharma ...
Read more: India will be world power in pharma, says Jhunjhunwala; is it time to buy?

Pharma Reviews: U.S. business rescues pharma cos in quarter one

The Indian pharmaceutical market (IPM) grew by 9.5% to Rs 9125 crore in ... Growth will be steered by US (~13% CAGR over FY16-18E) and Indian ...
Read more: U.S. business rescues pharma cos in quarter one

Pharma Reviews: Health ministry needs to revisit decision to ban antibiotic FDCs: Dr Gopakumar Nair

Many Indian pharma companies introduced oral formulations/dosage forms with 2 to 3 antibiotics with or without Lactobacillus. In antibiotic resistant ...
Read more: Health ministry needs to revisit decision to ban antibiotic FDCs: Dr Gopakumar Nair

Pharma Reviews: Pharmexcil to organise session in IAHSM to strengthen pharma trade between India, Africa

The India Africa Health Sciences Meet will be organised by Ministry of Health ... We will cover topics related to the establishment of Pharma industry, ...
Read more: Pharmexcil to organise session in IAHSM to strengthen pharma trade between India, Africa

Pharma Reviews: PPP model can make India one of top 5 global pharma innovation hubs: Study

PPP model can make India one of top 5 global pharma innovation hubs: Study New Delhi: To push India into top five pharmaceutical innovation hubs ...
Read more: PPP model can make India one of top 5 global pharma innovation hubs: Study

Pharma Reviews: India will be one of top 5 global pharma innovation hubs by 2020 through its PPP model: study

To push Indiainto top five pharmaceutical innovation hubs by 2020 and establish global presence by launching 1 out of every 5-10 drugs discovered ...
Read more: India will be one of top 5 global pharma innovation hubs by 2020 through its PPP model: study

US FDA News: FDA approves Erelzi, a biosimilar to Enbrel

The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.
Read more: FDA approves Erelzi, a biosimilar to Enbrel

Pharma Reviews: Govt to set new packaging standards for pharma exports

Mumbai, Aug 29: The Centre has directed the Indian Institute of Packaging (IIP) to set new packaging standards for pharmaceutical exports to African ...
Read more: Govt to set new packaging standards for pharma exports

Pharma Reviews: PPP model can make India one of top 5 global pharma innovation hubs: Study

Indian and foreign pharmaceutical companies are progressing with rising patented drug launches in India. The Indian Patent Office granted 2008 ...
Read more: PPP model can make India one of top 5 global pharma innovation hubs: Study

Pharma Reviews: Government To Amend Norms In 15 Days For Fixing Prices Of 350 Drugs

Calling pharma as the 'sunrise industry' which is growing at a rapid pace, Mr Kumar said the size of the Indian pharma industry is likely to cross USD ...
Read more: Government To Amend Norms In 15 Days For Fixing Prices Of 350 Drugs

Pharma Reviews: India To Be Among Top 5 Pharma Innovation Hubs By 2020

NEW DELHI: To push India into top five pharmaceutical innovation hubs by 2020, the government is preparing for multi-billion dollar investment with ...
Read more: India To Be Among Top 5 Pharma Innovation Hubs By 2020

Pharma Reviews: NPPA launches mobile App to provide real time drug prices

The Indian pharmaceutical industry has reached to almost $ 37 billion, with medicines being exported to over 200 countries. Pharmaceutical is a ...
Read more: NPPA launches mobile App to provide real time drug prices

Monday, August 29, 2016

Pharma Reviews: Drug prices control order to be amended, fix over 350 costly medicines

The minister said that pharma is the 'sunrise industry' of the country growing at a rapid pace. The size of the Indian pharma industry is likely to cross ...
Read more: Drug prices control order to be amended, fix over 350 costly medicines

Pharma Reviews: Lack of govt support puts pharma industry in MP in quandary, several SSIs closed

Lack of govt support puts pharma industry in MP in quandary, several SSIs closed ... on various occasions, but no use,” said Himanshu Shah, former secretary of the Indian Pharmaceutical Association, Madhya Pradesh branch.
Read more: Lack of govt support puts pharma industry in MP in quandary, several SSIs closed

Pharma Reviews: Pharma packaging sector requires more R&D to grow

MUMBAI : The Indian pharmaceutical industry is the third largest in terms of volume with a growth rate of 15-18 per cent per annum. But, the same ...
Read more: Pharma packaging sector requires more R&D to grow

Pharma Reviews: No bulk drug policy: Ananth Kumar

D G Shah, secretary general, Indian Pharmaceutical Alliance, said bulk drug parks alone would not encourage investors. One has to have an ...
Read more: No bulk drug policy: Ananth Kumar

US FDA News: Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards

Patients could take less than their intended lamotrigine dose, which may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.
Read more: Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards

US FDA News: Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels

Recall expanded to include all lots of DHZC-2 tablets. Distribution of all Life Rising products on hold until September 1, 2016.
Read more: Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels

Pharma Reviews: IIP to set specifications for pharma packaging

The Indian Institute of Packaging (IIP) is formulating packaging specifications for pharmaceutical products that are exported to several unregulated and ...
Read more: IIP to set specifications for pharma packaging

Pharma Reviews: Govt to set new packaging standards for pharma exports

The Centre has directed the Indian Institute of Packaging (IIP) to set new packaging standards for pharmaceutical exports to African and Asian ...
Read more: Govt to set new packaging standards for pharma exports

Pharma Reviews: States should come up with bulk drug parks to boost manufacturing: Ananth Kumar

D G Shah, secretary general, Indian Pharmaceutical Alliance, said that bulk drug parks alone will not encourage investors. One needs an environment ...
Read more: States should come up with bulk drug parks to boost manufacturing: Ananth Kumar

Pharma Reviews: Government launches mobile app to show drug prices

The pharmaceutical industry has risen to almost $37 billion and Indian medicines are being exported to over 200 countries. Pharmaceuticals is a ...
Read more: Government launches mobile app to show drug prices

Pharma Reviews: India to be amongst top five global pharma innovation hubs by 2020: Assocham

To push India into top five pharmaceutical innovation hubs by 2020 and establish global presence by launching one out of every five to 10 drugs ...
Read more: India to be amongst top five global pharma innovation hubs by 2020: Assocham

Pharma Reviews: Govt to amend norms in 15 days for fixing prices of 350 drugs

Calling pharma as the 'sunrise industry' which is growing at a rapid pace, Kumar said the size of the Indian pharma industry is likely to cross USD 50 ...
Read more: Govt to amend norms in 15 days for fixing prices of 350 drugs

Friday, August 26, 2016

Pharma Reviews: USFDA shoots warning letter to Frontida BioPharm for flouting quality practices

... related to manufacturing practices putting violations of data and manufacturing practices among Indian pharmaceutical industry back in the spotlight.
Read more: USFDA shoots warning letter to Frontida BioPharm for flouting quality practices

US FDA News: FDA advises testing for Zika virus in all donated blood and blood components in the US

As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
Read more: FDA advises testing for Zika virus in all donated blood and blood components in the US

Pharma Reviews: US FDA shoots warning letter to Frontida BioPharm

MUMBAI - Issues related to violations of data and manufacturing practices is back in the spotlight for the Indian pharmaceutical industry. An August 15 ...
Read more: US FDA shoots warning letter to Frontida BioPharm

Thursday, August 25, 2016

Pharma Reviews: US Patent Ruling On Teva's Copaxone A Big Win For India

US Patent and Trade Mark Office's decision to reject the patent claims of Teva Pharmaceutical Industries on its 40-milligram dosage of multiple ...
Read more: US Patent Ruling On Teva's Copaxone A Big Win For India

Pharma Reviews: Why are Indian pharma firms Brilliant, Celogen, Everest, others heading to LatAm; find out here

Indian drug makers are scouting for opportunities in the Latin American (LatAm) market to boost their exports, especially in Peru, Colombia, Panama ...
Read more: Why are Indian pharma firms Brilliant, Celogen, Everest, others heading to LatAm; find out here

Pharma Jobs: Project Coordinator

Company: Indegene Private Limited
Qualification: BCA, B.E/B.Tech, B.Sc
Experience: 1 to 3
location: Bengaluru / Bangalore
Ref: 19237273
Summary: Project Coordinator will be involved in end to end project management, performing coordination with various internal and external stakeholders and ensuring the work....

Read more: Project Coordinator

Pharma Jobs: Client Servicing Manager

Company: Indegene Private Limited
Qualification: B.B.A, BCA, B.E/B.Tech, B.Sc, MBA
Experience: 4 to 9
location: Bengaluru / Bangalore
Ref: 19237364
Summary: Candidate will be responsible to provide solutioning and being an SME to the Healthcare engagement activities and self driven professional to....

Read more: Client Servicing Manager

Pharma Jobs: Requirement Medical Representative at Assam

Company: Nueva Solutions India Private
Experience: 0 to 4
location: Barpeta, Dhubri
Ref: 19239883

Read more: Requirement Medical Representative at Assam

Pharma Jobs: Most Urgent Vacancy for Jr.Executive-Packaging Development-Navi Mumbai

Company: 2COMS Consulting Private Limited
Qualification: Any graduate
Experience: 2 to 4
location: Mumbai, Mumbai City, Navi Mumbai
Ref: 19240044
Summary: Candidate should be Working in a Pharma Company.Should be working in RND Department.2-4 years exp in Packaging & development in lab development or....

Read more: Most Urgent Vacancy for Jr.Executive-Packaging Development-Navi Mumbai

Pharma Jobs: JOB OPENING FOR ZAMIL AIR CONDITIONERS-SAUDI ARABIA

Company: Jerry Varghese International L
Experience: 3 to 10
location: Bengaluru / Bangalore, Chennai
Ref: 19241384

Read more: JOB OPENING FOR ZAMIL AIR CONDITIONERS-SAUDI ARABIA

Pharma Jobs: Most Urgent Vacancy for Analytical research and development-Formulation-Navi Mumbai

Company: 2COMS Consulting Private Limited
Qualification: M.Pharm, M.Sc
Experience: 3 to 6
location: Navi Mumbai
Ref: 19241981
Summary: Candidates should be working in Formulation.Should be dealing in to HPLC/GC etc.Dealing into ARD.Only candidates are preferred from Mumbai

Read more: Most Urgent Vacancy for Analytical research and development-Formulation-Navi Mumbai

Pharma Jobs: Looking for Periodic Safety Update Reporter(psur/dsur)

Company: Golden Opportunities Private Limited
Qualification: Any graduate
Experience: 1 to 6
location: Hyderabad / Secunderabad
Ref: 19243259
Summary: Skill/Responsibility: Prepare PSUR reports as per clients SOPs and WIs. Ensure delivery of quality PSUR report documents that objectively and accurately represent the....

Read more: Looking for Periodic Safety Update Reporter(psur/dsur)

US FDA News: Programmable Syringe Pumps: FDA Safety Communication - Problems With Fluid Flow Continuity at Low Infusion Rates

Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions.
Read more: Programmable Syringe Pumps: FDA Safety Communication - Problems With Fluid Flow Continuity at Low Infusion Rates

Pharma Reviews: Asian Paints, Hindustan Unilever top innovative Indian firms on Forbes' list

Asian Paints and Hindustan Unilever have been named the top Indian firms in ... Sun Pharma Industries (ranked 77) and construction group Larsen ...
Read more: Asian Paints, Hindustan Unilever top innovative Indian firms on Forbes' list

Pharma Reviews: Eight Indian companies in Forbes Asia's Fab 5...

The other Indian companies include Aurobindo Pharma, HDFC Bank, Motherson Sumi Systems, Sun Pharmaceutical Industries and three debutants ...
Read more: Eight Indian companies in Forbes Asia's Fab 5...

Wednesday, August 24, 2016

Pharma Reviews: Fosun can take Gland into a higher growth orbit: MD, Gland Pharma

Not just across the street by Dr Reddy's, Indian pharma major and others in India, but also in China by Shanghai Fosun Pharmaceutical Group, which ...
Read more: Fosun can take Gland into a higher growth orbit: MD, Gland Pharma

Pharma Reviews: For first time in 7 years, Pharma stocks lag Nifty50

Shares of Sun Pharmaceuticals, India's most valuable pharma company, which was an outperformer for the last six years, have lost over 6% in value ...
Read more: For first time in 7 years, Pharma stocks lag Nifty50

Pharma Reviews: With an aim of expansion, pharma companies like Lupin and Torrent eyeing acquisition in overseas

MUMBAI: India's top pharmaceutical companies are set to embark on an acquisition spree to bulk up their overseas presence. Lupin, Torrent, Zydus ...
Read more: With an aim of expansion, pharma companies like Lupin and Torrent eyeing acquisition in overseas

Pharma Reviews: Health Security At Stake

The issue has implications, not just for India's pharmaceutical exports, but also other key areas — especially in matters pertaining to access to ...
Read more: Health Security At Stake

Pharma Reviews: Five Indian companies ranked among world's 10...

ive major Indian companies including Asian Paints, Hindustan Unilever, Tata Consultancy Services, Sun Pharma and Larsen & Toubro have been ...
Read more: Five Indian companies ranked among world's 10...

Pharma Reviews: Aurobindo a bright spot in Indian pharma

Even as larger peers Sun Pharmaceutical and Lupin faltered on the bourses despite strong June quarter (Q1) earnings, Aurobindo Pharma gained ...
Read more: Aurobindo a bright spot in Indian pharma

Pharma Reviews: PIL in Delhi HC to stop launch of Indian company's stroke drug

Delhi high court on Wednesday sought the Centre and the drug controller general of India's (DCGI) response on a PIL seeking to stop an Indian ...
Read more: PIL in Delhi HC to stop launch of Indian company's stroke drug

Tuesday, August 23, 2016

Pharma Reviews: Fighting Animal Cruelty: Chemical Tests on Rabbits to Be Scrapped

The Drug Controller General of India has received representations to replace ... However, Sun Pharma, which is a major Indian pharmaceutical house ...
Read more: Fighting Animal Cruelty: Chemical Tests on Rabbits to Be Scrapped

Pharma Reviews: Medical reps' body protests undue sales pressure

According to him, this is part of the policy followed by management unions, Organization of Pharmaceutical producer of India (OPPI) and Indian Drug ...
Read more: Medical reps' body protests undue sales pressure

Pharma Reviews: DTAB backs plan to scrap drug tests on animals

However, Sun Pharma, which is a major Indian pharmaceutical house involved in new drug development including ophthalmic preparations, have ...
Read more: DTAB backs plan to scrap drug tests on animals

Pharma Reviews: India's pharma companies can benefit from Africa's health strategy

Accra: With a $106.8 million strategy to tackle Africa's public health emergencies over the next five years, stakeholders here feel it will be an ideal ...
Read more: India's pharma companies can benefit from Africa's health strategy

Pharma Reviews: Cipla In A State Of Flux

He went on to drive the company's new global vision. The Indian pharmaceutical major set up a corporate governing council led by professionals to ...
Read more: Cipla In A State Of Flux

Monday, August 22, 2016

Pharma Reviews: Data intergrity issues hamper relations with regulators: Strides

The Indian pharmaceutical industry has been reeling under regulatory issues over last few months. Before coming to a decision, one needs to see ...
Read more: Data intergrity issues hamper relations with regulators: Strides

Pharma Reviews: US FDA issues norms for classification of pharmaceutical co-crystals, seeks industry views by ...

US FDA has issued regulatory classification of pharmaceutical co-crystals guidance for ... The Indian pharma industry sees these guidelines as useful.
Read more: US FDA issues norms for classification of pharmaceutical co-crystals, seeks industry views by ...

Pharma Reviews: Generic pharma sectors earnings growth expectations still elevated

Generic pharma industry is seeing structural changes which along with the increased revenue base ($ 2 bn+) is driving Indian pharma's strategy to ...
Read more: Generic pharma sectors earnings growth expectations still elevated

Pharma Reviews: Doctors, drug companies mum on side-effects, patients suffer

"The lax system of approval of drugs in India, profit-oriented pharmaceutical companies who care two hoots (about patients), and doctors who are ...
Read more: Doctors, drug companies mum on side-effects, patients suffer

US FDA News: FDA Statement on Medical Device User Fee Agreement (MDUFA)

The FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of a medical device user fee program. Under the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in October 2017. This funding would provide critical resources to the FDA medical device review program. Details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.
Read more: FDA Statement on Medical Device User Fee Agreement (MDUFA)

Pharma Reviews: Price Curbs Hurt Domestic Revenue Growth of Indian Pharma Companies

The government's drug price controls have hurt domestic sales growth of Indian pharmaceutical companies, some of whom are already facing the ...
Read more: Price Curbs Hurt Domestic Revenue Growth of Indian Pharma Companies

US FDA News: FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury

The U.S. Food and Drug Administration today permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.
Read more: FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury

US FDA News: Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination

Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening.
Read more: Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination

Pharma Reviews: Indian pharma industry needs to create & promote 'Indian brands' of medicines, machineries ...

The manufacturers of pharmaceutical products, medical devices and machineries in the country should have a vision to promote Indian brands of ...
Read more: Indian pharma industry needs to create & promote 'Indian brands' of medicines, machineries ...

Pharma Reviews: 'Africa's health strategy can benefit India's pharma firms'

With a $106.8 million strategy to tackle Africa's public health emergencies over the next five years, stakeholders here feel it will be an ideal opportunity ...
Read more: 'Africa's health strategy can benefit India's pharma firms'

Sunday, August 21, 2016

Pharma Reviews: Top cos line up for Pharma Expo 2016 at Pragati Maidan

Key pharmaceutical manufacturing companies including ayurvedic and herbal product makers would participate in the 'Indian Pharma Expo 2016', ...
Read more: Top cos line up for Pharma Expo 2016 at Pragati Maidan

Pharma Reviews: Lindstrom in India works with more than 200 pharma companies : Anupam Chakrabarty

As India is poised to become the future world hub for the pharmaceutical industry, it needs to pay heed to maintaining global manufacturing standards, ...
Read more: Lindstrom in India works with more than 200 pharma companies : Anupam Chakrabarty

Saturday, August 20, 2016

Pharma Reviews: Gujarat gears up to woo fresh pharma investments as tax havens lose relevance

It is currently estimated to be around 30 per cent of the national pharma production. The Indian pharma industry is pegged at Rs 1 lakh crore.
Read more: Gujarat gears up to woo fresh pharma investments as tax havens lose relevance

Friday, August 19, 2016

Pharma Reviews: Meow-Meow scare for pharma industry

While the pharma industry faces increased scrutiny from investigators, the ... around 800-1,000 tonne of NDPS are manufactured in India every year.
Read more: Meow-Meow scare for pharma industry

Pharma Reviews: Russia to help India in four key industrial areas

Other fields identified to enhance cooperation included technology for production of CRGO steel in India, pharmaceutical industry, modernisation of ...
Read more: Russia to help India in four key industrial areas

US FDA News: Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter

Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
Read more: Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter

Thursday, August 18, 2016

Pharma Reviews: Awareness is the best methodology for India: Prof. (Dr.) Diptendra K. Sankar

WHO also recommends that for India we should be adopting our own ... research and therefore the whole Indian pharmaceutical industry must have ...
Read more: Awareness is the best methodology for India: Prof. (Dr.) Diptendra K. Sankar

US FDA News: FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery

The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery.
Read more: FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery

Pharma Reviews: Russia to help India in four key industrial areas

Russia agreed to help India in four key areas of civil aviation, fertilisers, ... technology for production of CRGO steel in India, pharmaceutical industry, ...
Read more: Russia to help India in four key industrial areas

US FDA News: Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution: Recall - Inadequate Seal of Blister Pack

Risk of sub-therapeutic dose as well as potential microbial contamination.
Read more: Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution: Recall - Inadequate Seal of Blister Pack

Wednesday, August 17, 2016

Pharma Reviews: Hyderabad based Dr.Reddy's Laboratories is India's 4th Most Reputed Pharmaceutical Brand ...

8 Hyderabad based brands made it to India's Most Reputed Pharmaceutical Brands list. Mumbai based Lupin Pharmaceuticals tops in Reputation in ...
Read more: Hyderabad based Dr.Reddy's Laboratories is India's 4th Most Reputed Pharmaceutical Brand ...

US FDA News: System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics: FDA Safety Communication - FDA Recommends Stop Using for Reprocessing Duodenoscopes

Health care facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
Read more: System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics: FDA Safety Communication - FDA Recommends Stop Using for Reprocessing Duodenoscopes

Pharma Reviews: Indian pharma majors dominate list of 'Top Most Reputed Pharmaceuticals Brand'

India's Most Reputed Pharmaceutical Brands study prepared by BlueBytes in association with TRA Research (both part of the Comniscient Group) has ...
Read more: Indian pharma majors dominate list of 'Top Most Reputed Pharmaceuticals Brand'

Pharma Reviews: Indian drugmakers brace for slower growth at home

Sun Pharmaceutical Industries Ltd, India's largest drugmaker, saw its domestic formulation sales rise 8% to Rs.1,854 crore in the first quarter, however ...
Read more: Indian drugmakers brace for slower growth at home

Pharma Reviews: What's ailing the pharma sector?

The other main foreign exchange earner for India, pharma industry posted subdued results, leading to depressed share prices, except for Cipla that ...
Read more: What's ailing the pharma sector?

Tuesday, August 16, 2016

Pharma Reviews: Indian cos looking to acquire US FDA approved API & formulation facilities to offset revenue losses

With rise in US FDA warning letters and import alerts to Indian pharma companies in recent years for not complying with good manufacturing practices, ...
Read more: Indian cos looking to acquire US FDA approved API & formulation facilities to offset revenue losses

Pharma Reviews: RELAXING CLINICAL TRIAL RULES

The situation was a result of growing criticism on the way trials were being conducted in India by certain pharmaceutical companies and contract ...
Read more: RELAXING CLINICAL TRIAL RULES

Monday, August 15, 2016

US FDA News: Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical: Recall - Raw Materials Issue

Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system.
Read more: Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical: Recall - Raw Materials Issue

Pharma Reviews: India's pharma dependence on China gets a cut, via duties

This step is expected to help the country reduce its dependence on China for imports of certain essential Active Pharmaceutical Ingredients (APIs), ...
Read more: India's pharma dependence on China gets a cut, via duties

Pharma Reviews: Breakthrough Innovative Products Launched at PharmaLytica 2016

Positioned as India's most Comprehensive Analytical and Contract Service Event, PharmaLytica 2016, brought the pharmaceutical fraternity under ...
Read more: Breakthrough Innovative Products Launched at PharmaLytica 2016

Pharma Reviews: Breakthrough Innovative Products Launched at PharmaLytica 2016

This year, PharmaLytica witnessed a massive turnout from exhibitors and visitors of the Pharma industry. Positioned as India's most Comprehensive ...
Read more: Breakthrough Innovative Products Launched at PharmaLytica 2016

Sunday, August 14, 2016

Pharma Reviews: Merck's Indian unit MSD may sell primary care drugs to focus on core brands

MUMBAI: MSD, the Indian unit of US pharmaceutical giant Merck, has put on the block a range of products as part of a rationalisation drive that will see ...
Read more: Merck's Indian unit MSD may sell primary care drugs to focus on core brands

Friday, August 12, 2016

US FDA News: NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results

The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.
Read more: NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results

US FDA News: DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk

Tablets have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children.
Read more: DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk

Pharma Reviews: Cash rich Indian pharma cos looking for acquisitions in regulated market: ICICI Securities

Considering high volume and profitability of generics in regulated markets like US, Europe, Japan, cash rich Indian pharma companies are targeting ...
Read more: Cash rich Indian pharma cos looking for acquisitions in regulated market: ICICI Securities

Thursday, August 11, 2016

Pharma Reviews: Results to watch out for! Sun Pharma,SBI, Cipla in focus

The results which are expected today are Sun Pharmaceutical Industries, State Bank of India, Cipla, Bank of India, Central Bank of India, Deepak ...
Read more: Results to watch out for! Sun Pharma,SBI, Cipla in focus

Pharma Reviews: Indian Pharma Market Regains Growth

Indian pharmaceutical market regained its growth momentum in July after a weak trajectory in the previous three to four months. According to drug ...
Read more: Indian Pharma Market Regains Growth

Pharma Reviews: Drug formulation market grows 9.5% in July to Rs 9125 cr

Mumbai, Aug 11 () Indian pharmaceutical drug formulation market grew 9.5 per cent to Rs 9,125 crore in July with Indoco Remedies leading the race ...
Read more: Drug formulation market grows 9.5% in July to Rs 9125 cr

Pharma Reviews: Sun Pharma Slips After U.S. Subsidiary Reports 11.8% Sequential Decline in Sales

Sun Pharmaceutical Industries Ltd.'s U.S.-based subsidiary Taro ... The proposed restructuring will create one of India's largest, well-diversified ...
Read more: Sun Pharma Slips After U.S. Subsidiary Reports 11.8% Sequential Decline in Sales

Pharma Reviews: Pharmexcil swings into action to contain drop in pharma exports

"Our meeting with USFDA and others show just by issuing these (letters) they don't have any doubt on capabilities of Indian industry," he said.
Read more: Pharmexcil swings into action to contain drop in pharma exports

US FDA News: FDA updates draft guidance on premarket safety notifications for dietary supplement industry

The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.
Read more: FDA updates draft guidance on premarket safety notifications for dietary supplement industry

Pharma Reviews: Drug formulation market grows 9.5% in July to Rs 9125 crore

Indian pharmaceutical drug formulation market grew 9.5 per cent to Rs 9,125 crore in July with Indoco Remedies leading the race with 27.8 per cent ...
Read more: Drug formulation market grows 9.5% in July to Rs 9125 crore

Pharma Reviews: No impact on CRISIL rating of pharma entities despite US FDA scrutiny

Says Akshay Chitgopekar, director, CRISIL Ratings: “India's pharmaceutical industry has to strengthen its systems and controls to address regulatory ...
Read more: No impact on CRISIL rating of pharma entities despite US FDA scrutiny

Wednesday, August 10, 2016

Pharma Reviews: Indian IT industry eyes life science and healthcare sectors to propel growth

With an increase in global forays by pharma, biotech and healthcare providers in India, the IT industry including Cognizant are witnessing significant ...
Read more: Indian IT industry eyes life science and healthcare sectors to propel growth

Pharma Reviews: Most drug makers hold on to their credit ratings despite FDA scrutiny

Several Indian companies, including major drug makers like Sun ... “India's pharmaceutical industry has to strengthen its systems and controls to ...
Read more: Most drug makers hold on to their credit ratings despite FDA scrutiny

Pharma Reviews: US Regulator's Scrutiny On Indian Drug Makers To Remain Intense: Crisil

Mumbai: Regulatory scrutiny of the US Food and Drug Administration (FDA) for domestic pharmaceutical facilities is expected to remain intense over ...
Read more: US Regulator's Scrutiny On Indian Drug Makers To Remain Intense: Crisil

Pharma Reviews: Pharma firms look at acquisition of niche product portfolios

Mumbai, Aug 9: Cash-rich large pharmaceutical firms in India are now looking at acquisition of niche product portfolios in regulated markets, a report ...
Read more: Pharma firms look at acquisition of niche product portfolios

Pharma Reviews: Pharma companies' profits will moderate in near term: CRISIL

Revenue growth and increase in research and development expenses will moderate profit growth of Indian pharmaceutical companies, rating agency ...
Read more: Pharma companies' profits will moderate in near term: CRISIL

Pharma Reviews: Pharmexcil swings into action to contain drop in pharma exports

During 2015-16, the Indian pharma industry achieved about 10 percent growth in exports with the value touching $17 billion. While the current ...
Read more: Pharmexcil swings into action to contain drop in pharma exports

Pharma Reviews: Pharmexcil swings into action to contain drop in pharma exports

Hyderabad, Aug 10: Pharma exports in the first quarter of fiscal 2016-17 ... During 2015-16, the Indian pharma industry achieved about 10 percent ...
Read more: Pharmexcil swings into action to contain drop in pharma exports

Pharma Reviews: Pharma exports down in Q1, Pharmexcil calls meetings

Pharma exports in the first quarter of fiscal 2016-17 have come down by 4-5 percent, causing concern among Pharmaceutical Export Promotion ...
Read more: Pharma exports down in Q1, Pharmexcil calls meetings

Tuesday, August 9, 2016

Pharma Reviews: SJM protests, demands withdrawal of new FDI policy

Saying that Indian pharmaceutical industry provides affordable drugs not only to the poor people of India but to the people of more than 200 countries, ...
Read more: SJM protests, demands withdrawal of new FDI policy

Pharma Reviews: Pharma firms look at acquisition of niche product portfolios

Mumbai, Aug 9 () Cash-rich large pharmaceutical firms in India are now looking at acquisition of niche product portfolios in regulated markets, a report ...
Read more: Pharma firms look at acquisition of niche product portfolios

Pharma Reviews: GST and considerations for the pharmaceutical industry

If implemented, GST will result in a complete overhaul of the Indian indirect ... The rate of GST applicable on pharmaceutical formulations is yet to be ...
Read more: GST and considerations for the pharmaceutical industry

Pharma Reviews: Pharma firms look at acquisition of niche product portfolios

Cash-rich large pharmaceutical firms in India are now looking at acquisition of niche product portfolios in regulated markets, a report said today.
Read more: Pharma firms look at acquisition of niche product portfolios

US FDA News: Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination

Use of B. cepacia contaminated product could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Read more: Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination

Pharma Reviews: Shanghai Surprise

A little-known Chinese pharma company buys an equally less known Indian firm for an astronomical valuation, and causes a stir in the industry.
Read more: Shanghai Surprise

Monday, August 8, 2016

Pharma Reviews: India Inc creates oral history to preserve legacy

Oral history interviews give an archivist the background to a company's ... "Cipla's story is in many ways the story of Indian pharma - its boom period ...
Read more: India Inc creates oral history to preserve legacy

Pharma Reviews: Analytical, bio-tech lab equipment sectors set for huge expansion

Analytical, bio-technology, lab equipment, pharma machinery and outsourcing services in India is set for huge augmentation owing to quality, research ...
Read more: Analytical, bio-tech lab equipment sectors set for huge expansion

Pharma Reviews: GAVIS Pharma LLC looking to exit Bengaluru-based Wintac Ltd

A year after Lupin sealed the biggest outbound acquisition by an Indian pharma major by buying US based Gavis Pharmaceuticals LLC and Novel ... in the pharmaceutical industry and has developed and commercialized more than ...
Read more: GAVIS Pharma LLC looking to exit Bengaluru-based Wintac Ltd

Saturday, August 6, 2016

Pharma Reviews: Poor get bitter medicine

Because though the government pushes hard to popularise generic drugs, Indian pharma companies are not manufacturing medicines according to ...
Read more: Poor get bitter medicine

Friday, August 5, 2016

US FDA News: 0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter

Administration to a patient may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.
Read more: 0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter

US FDA News: FDA issues draft updated recommendations on submitting a new 510(k) for device modifications

The U.S. Food and Drug Administration today issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
Read more: FDA issues draft updated recommendations on submitting a new 510(k) for device modifications

US FDA News: VentStar Oxylog 3000 Pediatric Patient Breathing Circuit by Dräger: Class I Recall - Potential Valve Leakage

Risk of serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death.
Read more: VentStar Oxylog 3000 Pediatric Patient Breathing Circuit by Dräger: Class I Recall - Potential Valve Leakage

Pharma Reviews: Pharma Industry Congregates at the Third Edition of PharmaLytica

UBM India, organisers of CPhI and P-MEC India, the leading global pharma trade show and conference, today hosted the 3rd edition of PharmaLytica ...
Read more: Pharma Industry Congregates at the Third Edition of PharmaLytica

Pharma Reviews: GST to benefit pharma industry, but pricing remains a concern

The Indian pharmaceutical industry, with a domestic turnover of over $15 billion, has been witnessing high growth over the past decade. But it is facing ...
Read more: GST to benefit pharma industry, but pricing remains a concern

Thursday, August 4, 2016

US FDA News: Kratom seized in California by US Marshals Service

The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000.
Read more: Kratom seized in California by US Marshals Service

Pharma Reviews: Buy Sun Pharmaceutical Industries Ltd., target Rs 925.0 : Motilal Oswal Securities

Buy Sun Pharmaceutical Industries Ltd., target Rs 925.0 : Motilal Oswal ... Sun Pharma remains one of Motilal Oswal's top picks in the Indian pharma ...
Read more: Buy Sun Pharmaceutical Industries Ltd., target Rs 925.0 : Motilal Oswal Securities

Pharma Reviews: Indian drug cos tap opportunities in Japan as govt pushes for generic drugs

Indian drug makers are exploring growth opportunities in Japan, the world's second-largest pharmaceutical market, as the local government is ...
Read more: Indian drug cos tap opportunities in Japan as govt pushes for generic drugs

Wednesday, August 3, 2016

Pharma Reviews: GST impact on Pharmaceuticals

There will be significant improvement in Indian Pharmaceutical industry's supply chain efficiency as well as a decline in manufacturing cost of ...
Read more: GST impact on Pharmaceuticals

US FDA News: Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter

Administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling, and blockage or clotting in blood vessels, which may be life-threatening if a critical organ is affected.
Read more: Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter

Pharma Reviews: 'Venezuela can pay dues to Indian pharma cos from oil exports'

The government has proposed to the crisis-ridden Venezuela that it can settle dues of pharma companies in India through oil that it exports here.
Read more: 'Venezuela can pay dues to Indian pharma cos from oil exports'

Tuesday, August 2, 2016

Pharma Reviews: IDMA keen in pharma industry adopting William Edwards Deming's 14 principles to meet ...

Indian Drug Manufacturers Association (IDMA) sees the need for robust and contemporary processes to be put in place by the pharma industry to ...
Read more: IDMA keen in pharma industry adopting William Edwards Deming's 14 principles to meet ...

Pharma Reviews: Indian Bank's Profit Up 42% in First Quarter; Asset Quality Weakens

The strategic asset purchase agreement between its Japanese subsidiary, Kyowa Pharmaceutical Industry Co Ltd., and Shionogi will be effective ...
Read more: Indian Bank's Profit Up 42% in First Quarter; Asset Quality Weakens

Pharma Reviews: Lupin to acquire 21 branded drugs from Japan's Shionogi for $150 mn

The company said the deal will help its Japanese subsidiary, Kyowa ... Other Indian pharmaceuticals companies have also been trying to increase ...
Read more: Lupin to acquire 21 branded drugs from Japan's Shionogi for $150 mn

Pharma Reviews: Lupin to buy 21 generic brands from Japan's Shionogi for $150 million

Hyderabad: Lupin Ltd, India's third largest drug maker, on Tuesday said it ... to strengthen its presence in the world's second largest pharmaceutical ...
Read more: Lupin to buy 21 generic brands from Japan's Shionogi for $150 million

Monday, August 1, 2016

Pharma Reviews: Sun Pharma Gains on Anti-Diabetes Drug Approval

Sun Pharmaceutical Industries Ltd. announced that one of its subsidiaries .... DoCoMo is seeking enforcement of that arbitral award in India and ...
Read more: Sun Pharma Gains on Anti-Diabetes Drug Approval

Pharma Reviews: Pharma industry to be included in 'thrust area' of industrial policy of Bihar government: IPGA Bihar

In a memorandum submitted to the government of Bihar by the state branch of the Indian Pharmacy Graduates Association (IPGA) has wanted it to ...
Read more: Pharma industry to be included in 'thrust area' of industrial policy of Bihar government: IPGA Bihar

US FDA News: Comfort Shield Barrier Cream Cloths by Sage Products: Recall - Product Contamination

Topical administration of a product with B. cepacia may cause serious, life-threatening infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups.
Read more: Comfort Shield Barrier Cream Cloths by Sage Products: Recall - Product Contamination

Pharma Reviews: Borosil acquires majority stake in Klasspack, enters primary pharma glass packaging business

With compliance becoming increasingly stringent in the Indian pharmaceutical sector, Borosil said it plans to combine its technological expertise in ...
Read more: Borosil acquires majority stake in Klasspack, enters primary pharma glass packaging business