trending Market Intelligence /marketintelligence/en/news-insights/trending/Alr4kt2hlvGiHfkB9bATLA2 content esgSubNav
In This List

Sanofi, Boehringer deal under regulatory scrutiny; Biogen names CEO

Case Study

Identifying PPE Suppliers During the Pandemic

Blog

Highlighting the Top Regional Aftermarket Research Brokers by Sector Coverage

Video

COVID-19 Impact & Recovery: Healthcare Outlook for H2 2021

Blog

Corporate Credit Risk Trends in Developing Markets: A Loss Given Default (LGD) Perspective


Sanofi, Boehringer deal under regulatory scrutiny; Biogen names CEO

* Novartis AG is acquiring private company Encore Vision Inc. to add a treatment for presbyopia to its ophthalmology pipeline. Texas-based Encore Vision is developing EV06, a topical treatment for presbyopia, the age-related loss of near-distance vision.

* Sanofi's planned $20 billion asset swap with Boehringer Ingelheim has come under scrutiny from Mexico's Federal Economic Competition Commission, Reuters reported. The regulatory body said it would approve the asset swap if Sanofi excludes Boehringer's cough medicine brands — Bisolvon, Mucosolvan and Sekretovit — from the merger, in order to avoid price fixing and to protect smaller competitors.

* Biogen Inc. named Michel Vounatsos CEO, replacing George Scangos. Vounatsos joined the company as executive vice president and chief commercial officer in April.

Drug and product pipeline

* GlaxoSmithKline PLC's two-drug HIV treatment regimen met its primary endpoint of non-inferiority in two phase 3 studies conducted by ViiV Healthcare. The studies evaluated safety and efficacy of shifting patients from a three- or four-drug antiretroviral regimen to the new treatment.

Meanwhile, GlaxoSmithKline and Innoviva Inc. initiated a phase 3 study of the once-daily Closed Triple combination therapy for patients with asthma. The study will compare the effects of the Closed Triple with the effects of the once-daily Relvar/Breo dual combination therapy.

* The Japanese Ministry of Health, Labour and Welfare approved Merck & Co. Inc.'s Keytruda for the first-line and second-line treatment of advanced non-small cell lung cancer in adults whose tumors have high PD-L1 expression. The approval is based on Keytruda's superior performance in a phase 3 trial, compared to chemotherapy.

* AbbVie Inc. submitted its glecaprevir/pibrentasvir drug to the U.S. FDA for approval to treat chronic hepatitis C. The FDA previously granted breakthrough therapy designation to the drug Sept. 30, for the treatment of patients who failed prior therapy.

* AstraZeneca PLC and Ionis Pharmaceuticals Inc.'s AZD8233 is moving to the preclinical development stage for the treatment of cardiovascular disease, resulting in a $25 million milestone payment for Ionis. AstraZeneca will be responsible for further developing and commercializing the drug candidate.

* Astellas Pharma Inc. secured marketing approval in Japan for Ironwood Pharmaceuticals Inc.'s LINZESS for the treatment of adults with irritable bowel syndrome with constipation.

* Meanwhile, Amgen Inc. and Astellas' joint venture, Amgen Astellas BioPharma KK, filed for marketing approval in Japan for its romosozumab, to treat osteoporosis in patients at high risk of fracture.

* The U.S. FDA granted fast-track designation to Astellas and Immunomic Therapeutics Inc.'s drug candidate ASP0892 for the mitigation of severe hypersensitivity reactions due to peanut allergy.

* The European Commission approved UCB SA's anti-epilepsy drug Vimpat as a monotherapy to treat partial-onset seizures in epilepsy patients over 16 years of age. The drug is approved in 44 countries as adjunctive therapy for the disease.

* Genmab A/S and Johnson & Johnson's Janssen Pharmaceutical K.K. submitted a new drug application for Darzalex with Japan's Ministry of Health, Labour and Welfare for the treatment of adults with relapsed or refractory multiple myeloma. The submission triggers a $10 million milestone payment for Genmab from Janssen.

* The European Commission expanded the coverage of Pfizer Inc.'s antibacterial vaccine Nimenrix to include use for infants. Nimenrix can now be administered to patients aged six weeks and older.

* Lannett Co. Inc. received the U.S. FDA's supplemental new drug approval for its morphine sulfate oral solution CII. The solution is indicated for the management of acute and chronic pain in opioid-tolerant patients.

* Clovis Oncology secured approval for its ovarian cancer drug Rubraca from the U.S. FDA. The drug is indicated to treat advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have BRCA gene mutations.

* The European Medicines Agency validated Sarepta Therapeutics Inc.'s marketing authorization application for Eteplirsen to treat a certain form of Duchenne muscular dystrophy. The company now seeks to secure conditional approval for the drug in the EU.

Operational activity

* Novartis AG signed an exclusive option, collaboration and license agreement with Conatus Pharmaceuticals Inc. to jointly develop emricasan, a drug used to treat liver disease. Novartis will make an upfront payment to Conatus of $50 million.

* Australian drug discovery company Phylogica Ltd. and Roche Holding Ltd.'s Genentech extended the exclusivity period of a research collaboration and license agreement for the discovery of novel antibiotics. Phylogica will receive a $2 million milestone payment as part of the deal.

* Portola Pharmaceuticals Inc. signed a $50 million loan agreement with Bristol-Myers Squibb Co. and Pfizer Inc. to provide additional funding toward development and clinical studies of AndexXa, a compound that is a potential antidote for factor Xa inhibitors for patients with uncontrolled bleeding.

* Japanese electronics company NEC Corp. is launching a new healthcare venture that will develop drugs using artificial intelligence. The company, Cytlimic Inc., will specialize in vaccines for cancer treatment.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, the Hang Seng dropped 0.47% to 21,729.06, while the Nikkei 225 rose 0.53% to 19,494.53.

In Europe, around midday, the FTSE 100 gained 0.16% to 7,028.14, and the Euronext 100 lifted 0.36% to 928.99.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.