Pfizer, BMS score FDA hat-trick with another Eliquis approval

Eliquis (apixiban) can now be used to treat and prevent deep-vein thrombosis (DVT) and pulmonary embolism (PE).

By Nicole Gray • Aug. 22, 2014

FDA approves GSK asthma inhaler Arnuity Ellipta

Arnuity Ellipta (fluticasone furoate) is a once-daily inhaler for asthma maintenance or prophylactic asthma therapy in patients aged 12 and up.

By Nicole Gray • Aug. 21, 2014

NICE reverses course, recommends Celgene's Revlimid for rare MDS form

UK's NICE had previously decided that Revlimid (lenalidomide) should not be funded for treatment of myelodysplastic syndrome (MDS) over questions of the drug's ability to extend lives.  

By Nicole Gray • Aug. 21, 2014

Hospira wins temporary restraining order against Precedex generics

A federal judge has issued a temporary restraining order blocking the FDA's decision to allow generic versions of Hospira's IV sedative.

By Sy Mukherjee • Aug. 20, 2014

1000s of companies revolt against Obamacare medical device tax

A federal audit finds that device tax revenues are far lower than expected, driven by companies' non-compliance.

By Sy Mukherjee • Aug. 20, 2014

Lilly, Boehringer win tentative FDA approval for Sanofi diabetes biosimilar

The provisional nature of the approval for this long-acting insulin is not based on safety concerns, but rather an ongoing patent-infringement spat with Sanofi. 

By Nicole Gray • Aug. 20, 2014

Novo hit with fine for stalling Tresiba rejection disclosure

The company denies any wrongdoing, but agrees to pay an $89,000 fine.

By Nicole Gray • Aug. 20, 2014

Pfizer files NDA for breast cancer breakthrough therapy

Palbociclib was designated as a breakthrough treatment by the FDA last year based on interim data showing significant improvements in progression-free survival (PFS) for breast cancer patients.

By Nicole Gray • Aug. 19, 2014

Eisai files thyroid cancer drug in US, EU

This first-in-class treatment was filed in Japan in late June. It has been granted orphan drug designation in Japan, the EU and the US.

By Nicole Gray • Aug. 19, 2014

Advocates slam NICE, Janssen over prostate cancer drug 'fiasco'

“It’s a fiasco,” said Owen Sharp, CEO of Prostate Cancer UK. “This decision is a kick in the teeth for men with advanced prostate cancer.”

By Nicole Gray • Aug. 19, 2014

FDA green lights Biogen MS drug

Plegridy is touted for being less painful for patients than Biogen's older MS blockbuster, Avonex.

By Sy Mukherjee • Aug. 18, 2014

Jilting generics: Part 2 of an exclusive interview with GPhA CEO Ralph Neas

Current REMS abuses are already costing more than $5 billion a year in savings. That number could rise sharply if biosimilars are blocked using the same strategy, warns Neas.  

By Nicole Gray • Aug. 17, 2014

FDA committee recommends approval of Boehringer COPD drug

In 2008, the FDA rejected Boehringer Ingelheim’s Spiriva Respimat (tiotropium) based on safety concerns. BI resubmitted its application for Spiriva in March.

By Nicole Gray • Aug. 17, 2014

Turkish citizens arrested for selling fake cancer drugs

Istanbul-based Ozay Pharma has been smuggling fake oncology medications into the US since 2004, according to federal prosecutors.

By Nicole Gray • Aug. 17, 2014

Word on the street: IPF drug maker InterMune is taking bids

Bidders are said to include Sanofi, Roche, GSK, and Actelion.

By Nicole Gray • Aug. 15, 2014

UK's NICE gives Gilead's Sovaldi a qualified 'yes'

The draft guidance from the UK’s National Institute for Health and Care Excellence (NICE) recommends Sovaldi's use for specific subtypes of chronic hepatitis C (HCV). 

By Nicole Gray • Aug. 15, 2014

FDA approves Avastin for treatment of metastatic cervical cancer

This top-selling oncology drug is the first biologic approved for the treatment of advanced cervical cancer.

By Nicole Gray • Aug. 15, 2014

Black box warnings and drug market withdrawals, by the numbers

The rise of FDA-approved drug market withdrawals and black box warnings corresponds with faster approval times and a reliance on industry fees to fund the agency's budget.

By Sy Mukherjee • Aug. 15, 2014

UPDATED: FDA issues consumer warning on fake Ebola drugs

"Individuals promoting these unapproved and fraudulent products must take immediate action to correct or remove these claims or face potential FDA action," said the agency on its website. 

By Sy Mukherjee • Aug. 15, 2014

Feds to investigate Valeant, Bill Ackman's Allergan takeover bid

The Securities and Exchange Commission (SEC) is in the early stages of probing Valeant and Ackman's Pershing Square's hostile takeover bid for botox-maker Allergan, sources say.

By Sy Mukherjee • Aug. 14, 2014

Roche backs out of $600 million development deal with Chiasma

Israel-based Chiasma is looking for a new partner to co-develop a promising investigational acromegaly drug. 

By Nicole Gray • Aug. 14, 2014

Jilting generics: Part 1 of an exclusive interview with GPhA CEO Ralph Neas

Generic Pharmaceutical Association (GPhA) president Ralph Neas says the misuse of REMS and other restricted access programs is costing billions in potential annual savings.

By Nicole Gray • Aug. 14, 2014

Celltrion submits FDA filing for biosimilar Remicade

This South Korean company is making history by filing the first submission for a biosimilar monoclonal antibody using the FDA’s new biosimilar pathway. 

By Nicole Gray • Aug. 14, 2014

Merck sleeping pill Belsomra gets FDA approval

Merck's sleeping pill has been touted for having less side effects than popular treatments like Sanofi's Ambien.

By Sy Mukherjee • Aug. 13, 2014

UPDATED: WHO endorses experimental treatments for Ebola patients

"[I]n the special circumstances of this Ebola outbreak, it is ethical to offer unregistered interventions as potential treatments or prevention," said WHO assistant director general Marie-Paule Kieny.

By Sy Mukherjee • Aug. 12, 2014