Jumping into the multibillion-dollar market for biosimilar insulin products seemed like a no-brainer for Merck & Co., which is one of the world’s leaders in diabetes.
But the company’s Lantus biosim partnership with Korea’s Samsung Bioepis has faced its share of challenges, not the least of which is a patent fight that has stymied its launch despite a tentative FDA approval last summer
Now Merck is ditching the biosimilar Lantus market altogether and shelling out cash to Samsung Bioepis for its costs, too. That leaves Mylan and its partner Biocon as the only major biosimilar players in a strong position to challenge Eli Lilly and Boehringer Ingelheim’s biosim Basaglar—and Sanofi’s Lantus brand itself, when its last patents expire in 2020.
Merck continues to work with Samsung Bioepis on other biosimilars in oncology and immunology, according to the statement. “We believe that biosimilars can present significant opportunities for cost savings through competition and improved patient access to therapies,” the company said. (See more details on FiercePharma)
Heralding an end for Changchun Changsheng Life Sciences, whose name literally means “long life,” a furious Chinese government handed out its verdict on the company’s role in a high-profile vaccine scandal that provoked nationwide anger and doomed the careers of several top-ranking government officials.
The Changchun, China-based vaccine maker will be fined a whopping 9.11 billion Chinese yuan ($1.32 billion) on eight violations of drug regulations, China’s National Medical Products Administration said in a release (Chinese) Tuesday as the agency concluded its investigation.
The sheer size of the punishment—rarely seen, if not unprecedented in China’s biopharma history—shows just how far Beijing is willing to go to placate public anger and deter future offenders that could damage its drug industry’s reputation.
Confirming what the agency had found during an on-site probe, the charges said Changsheng mixed different batches of active vaccine ingredients, including expired ones; failed to run proper efficacy tests; fabricated vaccine production dates; and manipulated or destroyed original records to cover its tracks. (cr. FiercePharma)
Last year, the U.S. Food and Drug Administration (FDA) approved what is perhaps the boldest use of digital technology in healthcare: a pill that is integrated with an ingestible sensor that captures information about whether the patient has complied with her medication regimen. A patient ingests the pill and it sends the data to a patch worn on her torso, which adds various physiologic measures. From there the information is wirelessly sent to a mobile phone app, allowing both the patient and her physician to track how the patient is using and responding to her medication. (See more details on FiercePharma)
China’s Zhejiang Huahai Pharmaceutical for years enjoyed the upside of the U.S. pharmaceutical market, selling its valsartan API to drugmakers producing blood pressure meds for the market. Now it is seeing the downside, having its products banned by the FDA and facing litigation over the discovery of a suspected carcinogen in its API.
The Chinese company disclosed (PDF) to the Shanghai Stock Exchange that it has been named in multiple lawsuits, according to a translated copy of the filing. The FDA said it has put Huahai on its import alert list, banning its products from the U.S. The company, whose APIs are in about half of the valsartan blood pressure medicines sold in the U.S., last summer instigated a global recall of its products. While the levels of NDMA in Huahai’s valsartan API were trace amounts, they were considered unacceptable, the FDA has said. Further testing has also found N-Nitrosodiethylamine (NDEA), another suspected carcinogen, in the API. (cr: FiercePharma)
The Food and Drug Administration conducted a surprise inspection of the headquarters of the e-cigarette maker Juul Labs last Friday, carting away more than a thousand documents it said were related to the company’s sales and marketing practices.
The move, announced on Tuesday, was seen as an attempt to ratchet up pressure on the company, which controls 72 percent of the e-cigarette market in the United States and whose products have become popular in high schools. The F.D.A. said it was particularly interested in whether Juul deliberately targeted minors as consumers.
CEPI, the global outbreak preparedness group, has been busy since it launched last year, raising more than $600 million and handing out grants to back research into neglected diseases. In its latest move, the coalition awarded $18.7 million to Johnson & Johnson and Oxford University’s Jenner Institute to support MERS, Lassa and Nipah vaccines.
Oxford and Janssen nabbed $14.6 million to support phase 1 testing and manufacturing for later phases of work on a Middle East Respiratory Syndrome candidate. If the adenovirus-vectored vaccine succeeds in a phase 1 test underway in the U.K., CEPI could award more money, and the partners could build an investigational stockpile to use in an outbreak. The deal also includes $4.1 million in funding for preclinical work on Lassa and Nipah vaccines.
CEPI, the Coalition for Epidemic Preparedness Innovations, formed last year with support from global nonprofits, governments and industry. So far, the coalition has reached $630 million of its $1 billion funding goal and has distributed tens of millions of dollars to support vaccine work against its priority targets. (See more details on FiercePharma)