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Breaking News on Global Pharmaceutical Technology & Manufacturing

Testosterone-makers must conduct cardio clinical trial, US FDA orders

04-Mar-2015 - The US Food and Drug Administration (FDA) has ordered makers of testosterone therapies to change their labelling and conduct clinical trials to investigate heart attack and stroke risk.

Regulations not the only barrier to biosimilars in the US say analysts

03-Mar-2015 - A robust US biosimilars market is still some way off according to analysts who say interchangability, doctors’ safety concerns and patient demands should be considered alongside the regulatory environment by firms mulling entry.

US FDA labelling change to all diabetes pens to prevent HIV risk

03-Mar-2015 - The US FDA is requiring manufacturers to place label warnings on all multi-dose diabetes pens as patients continue to share the devices.

Med Prep execs accused of lying about sterility practices at compounding facility

02-Mar-2015 - Med Prep Consulting execs committed fraud and violated the Federal Food, Drug and Cosmetic Act (FDCA) according to the US DoJ, which has accused the New Jersey compounder of knowingly selling drugs produced in unsanitary conditions.

People on the Move

Pharma's biggest movers

02-Mar-2015 -

Germany’s IQWiG questions transparency of proposed database of EU clinical trial results

27-Feb-2015 - The German Institute for Quality and Efficiency in Health Care (IQWiG) says the EMA’s proposal to establish a publicly accessible database of clinical trial data does not do enough to make the data transparent. 

update

Novartis ordered to halt drug production in Japan for 15 days

27-Feb-2015 - Novartis’s Japanese unit has been ordered to temporarily halt production of drugs by Japan’s health Ministry as punishment for delayed reporting of side effects.

Sagent shifts production in-house after US FDA concerns about CMO Emcure

25-Feb-2015 - Problems at Emcure Pharmaceutical have prompted US customer Sagent Pharmaceuticals to recall two lots of a muscle relaxant made by the CMO and take production in-house.

People on the Move

Who's on the move in pharma?

25-Feb-2015 -

Transcelerate teams to take on investigator selection bias

24-Feb-2015 - A register of clinical investigators can help eliminate bias according to Big Pharma Group Transcelerate, which has teamed with DrugDev to develop such a database.

EMA calls for industry involvement in applying new ISO standards to drugs

23-Feb-2015 - The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.

Celltrion: Remsima could save UK, Italy and France $336m in five years

20-Feb-2015 - Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK. 

Sanofi: deals like Lead Pharma accord not a replacement for in-house R&D

18-Feb-2015 - Sanofi has partnered with Dutch biotechnology spin-out Lead Pharma to discover autoimmune drugs that target ROR gamma t hormone receptors.

More US FDA draft guidance for compounders

16-Feb-2015 - The US FDA has proposed more new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.

update

Switzerland rejects allegations it offers drug fakers easy route to the EU

12-Feb-2015 - The increase in dodgy erectile dysfunction drugs seized in Switzerland does not mean the country is a weak point for counterfeiters shipping to Europe according to Swissmedic.

BMS follows Merck as glut of HCV drugs leads to loss of fast-track status

11-Feb-2015 - The US FDA has rescinded Breakthrough Therapy designation of a second HCV treatment, but Bristol-Myers Squibb says submission timelines for daclatasvir will not be affected.

EMA defends Humira redactions, says only commercial info was blacked out

10-Feb-2015 - The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’

Merck's loss of HCV Breakthrough status shows FDA's pragmatism, says analyst

10-Feb-2015 - Stripping Merck & Co.'s hep C pill of breakthrough status shows the US FDA is monitoring market developments in real-time warns one industry analyst. 

Dispatches from BIO CEO 2015

Experts say industry interactions with US FDA improving

10-Feb-2015 - Though it’s difficult to quantify, industry experts told investors at the BIO CEO conference in New York on Monday that the US FDA-industry interactions are improving though there’s still some inconsistency between FDA leadership, division directors and reviewers.

breaking news

Third time's a charm: Pfizer to buy Hospira for $17bn

05-Feb-2015 - Pfizer has entered into a definitive merger agreement to buy Hospira for $17bn.

UPDATE-2

US FDA Commissioner Margaret Hamburg to retire after six years

05-Feb-2015 - Margaret Hamburg will retire from her role as Commissioner of the US FDA after nearly six years.

UPDATE: Merck says switching cell lines would impact safety and quality

Anti-abortion group won't judge parents who choose Merck & Co's MMR vaccine

04-Feb-2015 - The anti-abortion group that blames Merck & Co for the recent US measles outbreak says it would not judge parents who have children vaccinated with MMR II for the good of society.

Think you’re on track for 2018 EU serialisation? No you’re not

04-Feb-2015 - Most pharmaceutical companies are already behind on preparations for the EU Falsified Medicines Directive’s serialisation requirements for 2018, says one services firm.

Two Indian manufacturers cited by FDA for data integrity issues

04-Feb-2015 - Bangalore, India-based Apotex and Verna, India-based Micro Labs both received warning letters last month from the US FDA detailing data integrity questions linked to their quality systems.

Novartis faces 15-day suspension by Japanese health ministry

03-Feb-2015 - The Japanese health ministry has warned Novartis it plans to suspend its business in Japan, a move the company says will bring “manageable” costs.

Spotlight

Third time's a charm: Pfizer to buy Hospira for $17bn
breaking news

Third time's a charm: Pfizer to buy Hospira for $17bn

Pfizer has entered into a definitive merger agreement to buy Hospira for $17bn.

Vertellus buys antiretroviral API reagent plant from Dow

Vertellus buys antiretroviral API reagent plant from Dow

Specialty chemicals firm Vertellus will continue to supply antiretroviral drugmakers sodium borohydride following its takeover of a...

ScinoPharm: profits fall on higher costs, an idle plant and lower Qsymia sales

ScinoPharm: profits fall on higher costs, an idle plant and lower Qsymia sales

ScinoPharm was hurt by weak US demand for the weight loss pill Qsymia, higher raw material prices...

Analyst: Pfizer's withdrawal from Repligen deal "not smart" amid growing Big Pharma interest in SMA

Analyst: Pfizer's withdrawal from Repligen deal "not smart" amid growing Big Pharma interest in SMA

Pfizer must act fast to convince investors it can compete with Roche and Biogen Idec for a...

MUGAS-funded Tamiflu analysis included fewer studies than Cochrane review

MUGAS-funded Tamiflu analysis included fewer studies than Cochrane review

Researchers claiming Tamiflu cuts flu symptom duration and hospitalisations analysed less than half as many studies as...