Emer Cooke, EMA director nominee

The EMA Management Board Thursday nominated Emer Cooke as the new executive director of the agency, selecting her from a shortlist of candidates created by the European Commission (EC). The next step in the process is for Cooke to give a statement to the European Parliament’s Committee on Environment, Public Health and Food Safety July 13, after which the board is expected to appoint the EMA executive director. Cooke, an Irish national, is currently the director of the World Health Organization’s Regulation and Prequalification Department, a position she’s held since 2016. Prior to that, she had a 14-year stint at the EMA serving as head of inspections and head of international affairs. Cooke’s 30 years of experience in international regulatory affairs also includes working in the EC’s pharmaceutical unit. She has master’s degrees in pharmacy, science and business administration from Trinity College in Dublin.

Novartis AG, of Basel, Switzerland, agreed to pay $112.8 million in disgorgement and interest to the SEC and consented to a cease-and-desist order issued Thursday. That’s on top of paying more than $233.9 million in a criminal fine as part of a three-year deferred prosecution agreement with the U.S. Department of Justice, the SEC said. The agreement settles SEC charges that Novartis violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act. According to the cease-and-desist order, local subsidiaries or affiliates of Novartis and its former subsidiary, Alcon Inc., used various schemes, between 2012 and 2016, to improperly pay public and private health care providers in Greece, South Korea and Vietnam in exchange for prescribing or using Novartis or Alcon drugs and medical devices. The SEC also found that Novartis lacked sufficient internal accounting controls within its former Alcon business in China, which used forged contracts as part of local financing arrangements that generated large losses and resulted in Novartis and Alcon writing off more than $50 million in bad debt. (Novartis, which had acquired Alcon in 2011, spun the business off in April 2019.)

The U.K.’s National Institute for Health and Care Excellence (NICE) Thursday recommended that certain people 12 years and older with advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumors be allowed to access Roche Holding AG’s Rozlytrek (entrectinib) through the Cancer Drugs Fund (CDF) while more data is collected to address any clinical uncertainties. The final draft decision makes Rozlytrek the second histology-independent drug to be recommended by NICE for CDF coverage. Earlier this year, NICE recommended Bayer AG’s Vitrakvi (larotrectinib) for a similar patient group on the CDF.

In a separate draft guidance Thursday, NICE said it is not recommending Novartis’ Mayzent (siponimod) for treating secondary progressive multiple sclerosis (MS). Instead, NICE is asking Novartis to include a comparison of Mayzent with best supportive care in its economic model, assuming a reduction in treatment effect over time. While trial results show that Mayzent reduces the number of relapses and slows disability progression compared with placebo, NICE said there is no evidence comparing the drug with interferon beta-1b, which is the only disease-modifying treatment currently available in the U.K. for people with active secondary progressive MS. NICE acknowledged that few people take interferon beta-1b, because of its side effects, including flu-like symptoms.

Novartis filed a complaint with the U.S. International Trade Commission claiming Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., violated section 337 of the Tariff Act with its import of certain prefilled syringes for intravitreal injection and components that infringe Novartis patents. Comments on public interest issues raised by the complaint should be submitted to the commission by July 3, according to a notice published in Thursday’s Federal Register.

Kicking off the next round of GDUFA negotiations, the FDA announced Thursday that it will hold a virtual public meeting July 21 to get public input on the reauthorization of the generic drug user fee agreement for fiscal years 2023 through 2027. The GDUFA III meeting will include presentations by FDA staff and stakeholder groups and allow public comment and discussion. Registration for the meeting closes July 7. Written comments will be accepted, at Docket No. FDA-2020-N-1459, through Aug. 20, 2020.

The FDA this week finalized its guidances on the clinical development of drugs to treat community-acquired bacterial pneumonia (CAPB) and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). The guidances discuss the overall development program and clinical trial designs for drugs to support an indication of CAPB or HABP/VABP.

Public Citizen submitted a citizen petition Wednesday asking the FDA to immediately require a boxed warning for all sodium-glucose co-transporter-2 (SGLT2) inhibitor drugs contraindicating their use in people with type 1 diabetes due to the increased risk of diabetic ketoacidosis (DKA). Current labeling for the type 2 diabetes drugs include warnings about that risk, but they are not the boxed warnings the FDA uses to call attention to serious or life-threatening risks. The petition cited “irrefutable evidence from multiple randomized clinical trials” that SGLT2 inhibitors canagliflozin (Invokana, Johnson & Johnson), dapagliflozin (Farxiga, Astrazeneca plc) and empagliflozin (Jardiance, Boehringer Ingelheim GmbH/Eli Lilly and Co.) cause a significant increase in the incidence of diabetic ketoacidosis when used to treat type 1 diabetes. Although it hasn’t been studied in type 1 diabetes, the most recently approved SGLT2 inhibitor, ertugliflozin (Steglatro, Merck & Co. Inc.), includes the same DKA warnings as the other drugs in the class, according to the petition.

The European medicines regulatory network issued recommendations this week to amend guidance on controlling impurities in drugs and clarify the roles and responsibilities of manufacturers. The recommendations also cover the management of impurities once they’re detected, communication with patients and health care professionals, and international cooperation. The new recommendations stem from lessons learned from the presence of nitrosamines, considered a probable carcinogen, in sartan blood pressure drugs.

As part of its new recommendations to fight antimicrobial resistance, the World Health Organization this week called on antimicrobial manufacturers to reduce the release of the drugs into waterways from their manufacturing processes. It also encouraged cooperation across public and private sectors to enhance efforts to reduce antimicrobial pollution throughout the drug supply chain.

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