Policy & Regulations

Big pharma companies join outsourcing queue

August 18th, 2009|

India emerging as a big global destination for contract manufacturing, unlike R&D outsourcing

Lilly Reports on Outcome of Phase III Study of Arzoxifene

August 18th, 2009|

x (NYSE: LLY) announced today that initial results from its pivotal, five-year, Phase III GJAD "GENERATIONS" trial for arzoxifene met its primary endpoints of significantly reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women.

Indian generics profit from Glaxo patent expiry

August 18th, 2009|

GlaxoSmithKline Plc’s anti-migraine drug brand, Imitrex, is turning out to be a good revenue earner for Indian generic companies, as the US Food and Drug Administration (FDA) has given almost half of the final approvals for the reverse engineered or generic versions of the drug made by Indian pharmaceutical companies, following its patent expiry.

Low costs a draw for foreign drug makers

August 10th, 2009|

Low costs, high technical capabilities and a skilled work force are making India an attractive destination for research and contract manufacturing of drugs

Impact Of Current Global Conditions On Pharma and Biotech

August 10th, 2009|

All major industries are facing a tough ride with the current global financial conditions, but the pharmaceutical/biotech industry is taking steps to overcome this situation.

MNCs eye Indian pharma

August 5th, 2009|

That slightly alarmist view is only partly true. Unlike big Indian auto and IT companies, pharma industry has still not reached the inflexion point where it can challenge big MNCs. Till a few years ago it was believed Indian pharma companies' highly profitable generic business model,they were able to corner a large share of market for drugs going off patent, and occasionally challenged patents through Para IV filings in the US, would allow them to build financial muscle.

India grants 3,500 pharma patents in three yrs

August 5th, 2009|

The Indian Patent Office (IPO) has granted 3,506 patents relating to pharmaceutical innovations over the last three years, the government said today.

Risk adjusted Vs absolute returns on pharma companies

August 2nd, 2009|

Nothing ventured, nothing gained is a popular Spanish proverb elucidating that taking risk is a prerequisite for expecting any higher return.

Can Emerging Markets Save Pharma?

August 2nd, 2009|

The emerging markets are the final frontier for pretty much every industry. The huge untapped markets have lots of potential, and pharmaceutical companies have jumped in full tilt.

Generic drugs to carry quality mark

August 2nd, 2009|

In a move to regulate quality in the Rs 35,000-crore generic drug market, the government now proposes to introduce quality mark for these drugs. The move will help consumers distinguish between quality and substandard medicines.

Pharma companies looking to Womens Health for growth

July 29th, 2009|

During menopause, women experience many symptoms associated with the natural change in hormone levels. Hot flashes and sexual dysfunction are the most prevalent symptoms, and if untreated can lead to sleep deprivation and even depression.

FDA Heat Fails to Scorch Appeal of Indian Pharma

July 28th, 2009|

Some Indian pharmaceutical companies are facing increased regulatory scrutiny in developed markets and that's perking up the view on the sector.

A Patently Good Idea

July 23rd, 2009|

Despite arguments from the pharma sector that the use of patents is a vital and necessary means of protecting revenue, many of the worst affected in a health crisis would simply be unable to afford potentially life-saving medication in the absence of alternatives offered by generic drug companies.

Watson seeks US FDA marketing nod for generic Sanctura XR

July 16th, 2009|

Watson Pharma, a leading specialty pharmaceutical company, confirmed that its subsidiary, Watson Laboratories, Inc-Florida (Watson), has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market its trospium chloride extended-release 60 mg capsules prior to the expiration of a patent owned by Supernus Pharmaceuticals, Inc.

Indian pharma firms swallow bitter pill in US, Europe

July 15th, 2009|

Last week, Lupin, Matrix Laboratories and Unichem Laboratories’ UK subsidiary Niche Generics figured in the list of companies under investigation by the European Commission for “knowingly delaying” the generic launch of a cardiovascular drug, Perindopril, by teaming with the innovator of the drug, Laboratories Servier. The European Commission said it would probe anti-trust violations against these manufacturers.

Pharma Accused of Keeping Good Generics Down

July 15th, 2009|

The European Commission has accused the pharmaceutical industry of delaying the entry of generic drugs to the market. As a result, it intends to step up its scrutiny of the sector under EU antitrust law. “We must have more competition and less red tape in pharmaceuticals,” claimed Competition Commissioner Neelie Kroes.

Pandemic flu shows need for pharma incentives WHO

July 14th, 2009|

Pharmaceutical firms need incentives, including lucrative patents, to keep creating drugs and vaccines against emergent threats such as the H1N1 influenza pandemic, the World Health Organisation's head said on Tuesday.

Sun Pharma: A dose of good news

July 13th, 2009|

The US authorities still need to bless the settlement that Sun Pharma has entered into with Forest Laboratories Holdings (FRX) over the patent litigation for Lexapro,an anti-depressant. However, the Street cheered the move and the stock was up 2 per cent in an otherwise weak market.

Dark clouds loom on Big Pharma horizon

July 13th, 2009|

Big Pharma initially coped better than other sectors with recession but has begun to underperform, and bleak prospects of more competition, problems getting new drugs to market and cheaper medicines are looming on investors' radars.

Pharma cos can approach NPPA for redressing overcharging issue

July 13th, 2009|

Even as the district collectors in several states have started executing recovery proceedings against several pharma companies for overcharging of various drug formulations, the National Pharmaceutical Pricing Authority (NPPA) has clarified that individual companies are welcome to approach the NPPA for redressing any grievances regarding the overcharging issue.