FDA: Page 115
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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 -
Deep Dive
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The draft guidance from the UK’s National Institute for Health and Care Excellence (NICE) recommends Sovaldi's use for specific subtypes of chronic hepatitis C (HCV).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 -
Deep Dive
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 -
Deep Dive
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 -
FDA
Deep DiveDoes faster regulatory approval translate into safety problems?
Expedited reviews. Postmarketing requirements. Encouraging innovation. The FDA is trying to balance stakeholders' needs and desires while honoring the Prescription Drug User Fee Act.
By Nicole Gray • Aug. 12, 2014 -
FDA green lights J&J's 2-in-1 diabetes drug
Johnson & Johnson's Invokamet is a fixed-dose combination of Invokana (canaglifozin) and metformin.
By Nicole Gray • Aug. 12, 2014 -
EU launches landmark decentralized generic drug approval pilot program
Under the International General Drug Regulators Pilot Program (IGDRP), just one approval grants marketing authorization in several countries simultaneously.
By Nicole Gray • Aug. 11, 2014 -
UK regulators say Roche's Kadcyla is too expensive
National Health Services (NHS) says the drug, combined with Herceptin as a new treatment option for inoperable, HER2-positive, metastatic breast cancer, is too pricey.
By Nicole Gray • Aug. 11, 2014 -
Sex, drugs, and bribes: More on GSK's Chinese misadventures
Unraveling a complex web of bribery allegations, sexual innuendo, and dishonest informants.
By Nicole Gray • Aug. 11, 2014 -
WHO panel to debate ZMapp, ethics of experimental Ebola treatments
The World Health Organization (WHO) is convening a panel on Monday to discuss the ethical issues surrounding administering largely untested experimental treatments during public health emergencies.
By Sy Mukherjee • Aug. 11, 2014 -
Chinese authorities imprison GSK sex tape investigator, wife
GlaxoSmithKline's strange saga in China takes a new twist.
By Sy Mukherjee • Aug. 8, 2014 -
EMA green lights Pfizer bid to broaden pneumonia vaccine use
The goal is to expand use of Prevnar 13 in older adults beyond prevention of invasive pneumococcal disease.
By Nicole Gray • Aug. 8, 2014 -
AbbVie-Shire, other inversions on the chopping block as government mulls action
President Obama and the US Treasury are looking for ways to stop American corporations from moving their headquarters offshore.
By Nicole Gray • Aug. 8, 2014
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