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

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

SEC HQ picture credit wikipedia/D Ramey Logan

Patheon: Irix deal about US and Canadian customer demand for local APIs; all staff to be retained

Irix Pharmaceuticals will cater for North American customers’ desire for local supply according to Patheon, which says it plans to retain the API firm’s 180 staff.

Health Canada looks to crack down further on noncompliant manufacturers

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.

Production of wart drug with anti Ebola potential set to restart in New Jersey

Hemispherx will make a candidate Ebola treatment being trialled by the US military at its revamped plant in New Jersey.

Hundreds of API suppliers with plants in new Indian state Telangana need to update EDQM

As many as 450 API and intermediate suppliers in India's newest State - Telangana – need to log their changed addresses with the EDQM before August.

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

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.

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...