Business-in-Brief

Regulation

• The recent furor over drug prices appears to have had an impact in California, with the state’s Governor Jerry Brown recently signing legislation into effect that requires drug manufacturers to give California at least 60 days’ notice if prices are increased by more than 16 percent in two years. The law has been applied in an effort to offer greater transparency to the general public about changes in drug pricing.
• During a speech about understanding competition in prescription drug markets, FDA Commissioner Scott Gottlieb announced that the US agency is planning to increase the scope of expediting generic drug application reviews, while maintaining safety and efficacy. The FDA has also been in discussions with the US Federal Trade Commission about the move, as the agency believes it may reduce drug costs because of increased competition in the market. 
• Amsterdam has been selected as the new host city for the EMA. After hours of deliberation, and votes being tied 13-13 between Milan and Amsterdam, the location was chosen by a coin toss. The agency must take up operations in its new home by March 30, 2019, at the latest.

Manufacture

• Hoping to future proof their manufacturing operations, Sanofi is investing in digital technologies, spanning from virtual reality to collaborative robotics, and plans to develop the next generation of biopharmaceuticals within digital manufacturing plants. They expect their shift towards biologics to result in an investment of approximately €600 million per year by 2020 to boost their capacity.
• Allergan is once again in the spotlight as it faces price-fixing allegations, with investors attempting to sue the company. It is alleged that Allergan colluded with other companies to create artificially inflated prices of propranolol, ursodiol, doxycycline, desonide, tretinoin, glyburide-metformin, and verapamil, between October 2013 and November 2016.
• Janssen Biotech, a subsidiary of J&J, has dropped its lawsuit against Samsung Bioepis with “great prejudice,” meaning they cannot re-file the motion. The initial suit was filed regarding a patent on Janssen’s Remicade, which Janssen believed was violated by Samsung Bioepis’ Renflexis. After the ruling in the Sandoz versus Amgen case, two of Janssen’s complaints were rendered moot, as they would have locked Samsung in a “patent dance” (Samsung would have to disclose their ordinarily private application information to Janssen). The landmark Sandoz versus Amgen case saw the US Supreme Court dismiss the patent dance, despite its basis in the Patient Protection and Affordable Care Act.

Warning Letters

• Lupin has been trying for some time to bring its plant in Goa, India, up to scratch but an FDA warning letter suggests that the company is struggling. The letter applies to both the Goa facility and another Indian plant in Indore, and states that the company’s improvement efforts so far are not adequate. The FDA also adds that the company is repeating the same mistakes despite earlier direction. Most of the issues raised relate to product testing, with batches of drugs failing to meet specifications. 
• Drug manufacturer Guangdong Zhanjiang Jimin Pharmaceuticals has received a warning letter from the FDA about several “significant violations of current good manufacturing practice” after an inspection of the company’s manufacturing facility in China. The violations include inadequate quality control – including approving multiple lots of a drug for distribution in the US containing the wrong API – as well as product misbranding, and failure to establish adequate written procedures.