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Regulatory & Safety: Top Headlines

Health Canada looks to crack down further on noncompliant manufacturers

04-Mar-2015 - Health Canada is telling drug and API manufacturers that it’s going to ramp up announced and unannounced inspections due to concerns raised around APIs and data integrity, and the findings will be published online beginning next month.

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News in brief

SEC calls on pharma companies to be more forthcoming with FDA disclosures

04-Mar-2015 - The SEC’s enforcement director is calling out pharma companies for failing to disclose and misinforming investors about correspondence with the US FDA.  

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 - Big management changes at US FDA, GSK, and Association of the British Pharmaceutical Industry.

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. 

Regulatory & Safety: Featured news

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...