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Breaking News on Global Pharmaceutical Technology & Manufacturing

Update

Pfizer considers splitting company or going after M&A

27-Jan-2015 - Pfizer says it is considering breaking up the company in 2015, or alternatively continuing its pursuit of a major acquisition.

US Senator proposes NIH to be funded through Big Pharma ‘swear jar’

26-Jan-2015 - Pharma firms that break the law could be fined one percent of their blockbuster drug revenues if proposed US legislation is introduced.

News in brief

30 months for smuggler of Roche cancer drugs which lacked API

26-Jan-2015 - A second man has received a prison sentence after counterfeit vials of a Roche cancer drug containing no API were seized in 2012.

People on the Move

CEOs found for BSM and Repligen

26-Jan-2015 -

Syrzia win may land pharma with more Greek debts, analyst

26-Jan-2015 - Syriza's election victory may prompt drugmakers already burdened with unpaid Greek bills to rethink their presence in the country according to one analyst.  

FDA's wearables guidance could slow pharma adoption in short-term, says analyst

22-Jan-2015 - Draft guidance distinguishing wearable medical devices from ‘general wellness’ devices could slow pharma’s adoption of such data in the short-term, according to an analyst.

Antibiotics "a terrible business model" for Pharmas expert tells Davos

22-Jan-2015 - Drug industry execs at the World Economic Forum in Davos, Switzerland were told they are no longer best placed to develop antibiotics by a panel who said Governments should lead efforts to create these vital new drugs.

State of the Union: Obama’s fast-track trade plans divide pharma

22-Jan-2015 - President Obama in his State of the Union address has called for the power to personally make stronger trade agreements – bringing divisive EU deal TTIP closer to adoption and angering campaigners for drugs access.

EMA supply interuption rules need clarification says industry; NGO says high prices cause shortages

21-Jan-2015 - Rules governing when drugmakers should warn regulators about supply interruptions need to take mitigation plans into account according to European industry groups.

EMA expands generic assessment pilot globally in response to industry

21-Jan-2015 - The EMA has responded to feedback from generic drugmakers by broadening an assessment sharing pilot to regulators outside the EU.

MHRA: Wockhardt non-compliance includes all APIs for EU market

20-Jan-2015 - Following Wockhardt’s decision to cease supplying APIs to the EU market, the UK drug regulator MHRA (Medicines and Healthcare Products Regulatory Agency) has updated its statement of noncompliance to include all APIs made from the India-based manufacturer.

People on the Move

Astellas, Sanofi, Unilife... the latest senior hires in pharma

19-Jan-2015 - in-Pharmatechnologist.com takes a look at the People on the Move this week.

Swiss franc movement sees Roche, Novartis, Actelion and Lonza shares plummet

15-Jan-2015 - The value of the Swiss franc fluctuated today after the country’s central bank abandoned its minimum Euro exchange rate in a shock move that saw shares in Roche, Novartis, Actelion, SGS and Lonza fall.

update

US FDA rejects Pharmexcil claims it no longer lets Indian regulators know about inspections

14-Jan-2015 - The US FDA has rejected Pharmexcil claims it no longer informs Indian regulators of manufacturing plant inspections and said its policy is to invite host-country inspectors to attend visits.

Drug disposal not our problem, industry tells Supreme Court

14-Jan-2015 - Industry groups PhRMA, BIO and GPhA are petitioning the Supreme Court to overturn a local law that requires pharma companies to cough up payment for safe disposal of medicines which make their way to one county.

Competition

'On Immunity': enter BioPharma-Reporter.com’s free book giveaway

13-Jan-2015 - Did you know that throughout the nineteenth century, vaccination left a scar known as “the mark of the beast”? Or that parents believed vaccination would cause children to grow cows’ horns?

people on the move

Who's on the move?

13-Jan-2015 - The WHO Executive Board prepares for a special Ebola meeting, CEO leaves troubled biotech, and senior staff hired at Bayer and Immunocore...

US FDA launches overarching Office of Pharmaceutical Quality

13-Jan-2015 - Industry won’t see much of an initial impact from the US FDA’s newly formed Office of Pharmaceutical Quality, though in a couple of years the agency will have more benchmarks and new technology to find and single out the worst manufacturers. 

EMA orphan approval hike reflects biology advances and pharma economics says expert

12-Jan-2015 - The record number of orphan drugs approved in Europe last year reflects the pharma industry’s need to refill pipelines and scientific advances says Genetic Alliance UK

FDA blocks Australia site from importing tainted Cialis as Lilly claims innocence

12-Jan-2015 - The US FDA has published an import alert for an Australian manufacturing site of Eli Lilly after the agency found that its Cialis pills were tainted with the active ingredient of another popular ED (erectile dysfunction) drug -- Pfizer’s Viagra. 

Judge rules Mylan monopoly suit against Celgene can continue

12-Jan-2015 - Mylan lawsuit accusing Celgene of using REMS to block generic Revlimid and Thalomid should go to trial says US Court.

Illicit vendors using YouTube to advertise fake drugs, says MHRA

08-Jan-2015 - Regulatory enforcement saw fewer counterfeit drug websites in 2014 but sellers are turning to YouTube and social media sites to advertise their products, according to the MHRA.

After Warning Letter, a recall for Hospira injectables

08-Jan-2015 - Hospira has recalled ten lots of injectable Mitoxantrone it says are subpotent and contain impurities.

FDA defiant on orphan exclusivity rules even after court judgement

07-Jan-2015 - The US FDA says it will stick to its policy on orphan drug exclusivity despite a conflicting court ruling.

India aims to make new clinical trial rules permanent with draft bill

07-Jan-2015 - India’s CDSCO (Central Drugs Standard Control Organization) has released a new draft bill  that would amend the country’s landmark law governing pharmaceuticals from 1940.

Spotlight

'On Immunity': enter BioPharma-Reporter.com’s free book giveaway
Competition

'On Immunity': enter BioPharma-Reporter.com’s free book giveaway

Did you know that throughout the nineteenth century, vaccination left a scar known as “the mark of...

Illicit vendors using YouTube to advertise fake drugs, says MHRA

Illicit vendors using YouTube to advertise fake drugs, says MHRA

Regulatory enforcement saw fewer counterfeit drug websites in 2014 but sellers are turning to YouTube and social...

Resistance is…years away: New compound could delay post antibiotic era

Resistance is…years away: New compound could delay post antibiotic era

Discovering a new antibiotic candidate and finding out how it kills superbugs without letting resistant mutants escape...

Oil's well that ends well? Low Brent crude price a boon for pharma says analyst

Oil's well that ends well? Low Brent crude price a boon for pharma says analyst

Falling oil prices will cut drug industry materials, manufacturing and logistics costs, and protect firms at risk...

Gilead strikes back at AbbVie with exclusive payer deal for hep C drug

US pharmacy deals could cut costs of AbbVie and Gilead's HCV treatments

Gilead and AbbVie’s exclusive deals with payers CVS and Express Scripts could help cut the cost of...

Not prepared for track & trace? US FDA grants amnesty until May

Not prepared for track & trace? US FDA grants amnesty until May

The US FDA will give drugmakers and distributors until May to comply with new track and trace...

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