Novo Nordisk faces delay for insulin combo

The setback could give rival Sanofi a crucial one-month edge over Novo in the race to bring an insulin combo product to market. 

By Lisa LaMotta • Sept. 6, 2016

FDA strengthens warnings on opioids, benzodiazepines

The new actions taken this week are part of the agency's widening efforts to combat the opioid abuse epidemic. 

By Suzanne Elvidge • Sept. 2, 2016

Tonix preps to enter PTSD market

The biotech cleared Phase 2 and is readying its lead compound for late-stage trials.

By Lisa LaMotta • Aug. 31, 2016

Novartis wins US approval for biosimilar Enbrel

Erelzi is only the third biosimilar drug approved in the U.S., following copies of Amgen's Neupogen and Johnson & Johnson's Remicade. 

By Ned Pagliarulo • Aug. 30, 2016

Biosim threat stiffens for Roche's Herceptin

A number of Roche's top-selling cancer drugs face looming competition from biosimilars in both the U.S. and Europe. 

By Ned Pagliarulo • Aug. 28, 2016

Theranos planning appeal of federal penalties

Health regulators last month handed down sweeping sanctions to the blood-testing company, banning founder Elizabeth Holmes from the business for two years. 

By Ned Pagliarulo • Aug. 26, 2016

Sagent recalls injectable antibiotic

One lot of Oxacillin is being pulled from the market after metal particulate was found in a vial of the drug. 

By Ned Pagliarulo • Aug. 25, 2016

FDA unexpectedly snubs Amgen drug

Approval had been expected for the drug, a treatment for a type of hormone imbalance in patients with chronic kidney disease. 

By Ned Pagliarulo • Aug. 25, 2016

With PDUFA date for rucaparib set, Clovis eyes rebound

A high-profile failure of Clovis' lung cancer drug earlier this year had led the company to cut a third of its staff and pin its hopes on rucaparib. 

By Ned Pagliarulo • Aug. 24, 2016

Puma's neratinib closing in on EU market

European regulators accepted a filing for the biotech's breast cancer drug, despite known gastrointestinal issues caused by the drug. 

By Suzanne Elvidge • Aug. 23, 2016

Amgen refutes 'flawed' cholesterol study

The big biotech pushes back against a recent medical journal article that criticized its cholesterol drug pricing. 

By Suzanne Elvidge • Aug. 22, 2016

FDA delays Sanofi's diabetes combo

The three-month delay occurred because Sanofi submitted new information about the drug’s pen-delivery device at the FDA’s request, which resulted in a “major amendment” to the original NDA.

By Kirell Lakhman • Aug. 22, 2016

Chinese/Indian manufacturing facilities facing repercussions

All products coming from the Indian company, Laxachem Organics, are banned from importation into the U.S.

By Nicole Gray • Aug. 18, 2016

Another Indian API facility added to EU's 'do not import' list

German inspectors found close to 35 issues at the Artemis Biotech facility. 

By Nicole Gray • Aug. 18, 2016

Avalere: FDA fees are outpacing drug approvals

Manufacturer's user fees have been increasing, but so has the number of drugs approved. One report says that more can be done to increase efficiency at the FDA. 

By Lisa LaMotta • Aug. 17, 2016

Ipsen hopes to be David to Allergan's Goliath

The French biotech is hoping a new indication for its boulinum toxin Dysport will allow it to compete more effectively with Allergan's market-leading Botox. 

By Nicole Gray • Aug. 17, 2016

Boehringer seeks real-world data to support reversal agent

The pharmaceutical company is hoping to bolster sales of Pradaxa with real-wrold data supporting the use of its anti-coagulant reversal agent Praxabind. 

By Nicole Gray • Aug. 16, 2016

Chinese regulators advance overhaul of drug manufacturing

Draft guidelines released last week are a continuation of CFDA's efforts to raise quality standards for domestically produced drugs. 

By Ned Pagliarulo • Aug. 15, 2016

Endo ditches pursuit of abuse-deterrence for Opana

The specialty pharmaceutical company has withdrawn its sNDA after discouraging discussions with regulators. 

By Lisa LaMotta • Aug. 15, 2016

Shire launches new treatment for hereditary bleeding disorder

Vonvendi is the first recombinant replacement treatment for von Willebrand disease, a condition with very few treatment options currently on the market.

By Nicole Gray • Aug. 10, 2016

Hopes of early end to Lilly breast cancer trial dashed

The big pharma's CDK 4/6 inhibitor will continue through its Phase 3 program as planned, but Lilly had hoped the trial would be stopped early.

By Lisa LaMotta • Aug. 10, 2016

Pfizer temporarily shutters Indian facility after inspections

Acquired in last year's Hospira deal, the site near Chennai had previously been flagged by U.S. regulators in 2013 for manufacturing violations. 

By Ned Pagliarulo • Aug. 9, 2016

BIO president defends Orphan Drug Act after op-ed criticism

Jim Greenwood, president and CEO of BIO, contends that the Orphan Drug Act has been a success, despite recent attacks saying it facilitates high drug pricing. 

By Nicole Gray • Aug. 9, 2016

Merck locks up another cancer approval for Keytruda

Merck's latest success comes on the heels of Bristol-Myers Squibb's CheckMate-026 failure in non-small cell lung cancer. 

By Nicole Gray • Aug. 8, 2016

Novartis creeps in on Pfizer's Ibrance

The Swiss giant's oncology strategy is coming together as a Breakthrough Therapy designation moves it closer to filing on one of its key growth drivers. 

By Lisa LaMotta • Aug. 4, 2016