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US lifts ban on 'monster germs'; senator says tax bill makes ACA unworkable

Top news

* The U.S. government lifted a temporary ban imposed three years ago on funding research that modifies pathogens — such as the flu virus and the virus that causes Middle East respiratory syndrome, or MERS, and severe acute respiratory syndrome, or SARS — to make them more deadly to pursue knowledge that would benefit humans, The New York Times wrote. Critics fear the labs could create a "monster germ" that would lead to a pandemic, the paper said.

* Industry experts told S&P Global Market Intelligence that a provision in the U.S. tax bill that would repeal the Affordable Care Act's individual mandate penalty would undermine the law's purpose of insuring more Americans and that the impact on the health insurance industry could be severe.

Sen. John Cornyn, R-Texas, said the tax bill will make the ACA "unworkable," and he hopes this would compel Democrats to agree on a bipartisan deal to replace the law, Bloomberg News wrote.

According to analysts, several companies from the healthcare sector — including Cardinal Health Inc., Quest Diagnostics Inc. and Universal Health Services Inc. — will benefit from the tax reform bill when it becomes law, Reuters noted.

* Spark Therapeutics Inc.'s Luxturna, or voretigene neparvovec, secured approval from the U.S. Food and Drug Administration to treat patients with a type of retinal dystrophy that leads to vision loss and can cause complete blindness.

On the policy front

* The FDA is proposing stricter rules for awarding orphan drug designations to therapies intended for children, saying it would only grant them if the use of the medicine in the pediatric subpopulation meets the regulatory criteria for an orphan subset, or if the disease in children is different from that in adults.

M&A and capital markets

* Strides Shasun Ltd.'s Singapore unit agreed to acquire a 55% stake in South Africa-based Trinity Pharma Pty. Ltd. for a cash consideration of 55 million South African rand.

* JSR Corp. is acquiring the entirety of Crown Bioscience International for an estimated purchase price of NT$12 billion.

* Impax Laboratories Inc. will sell its manufacturing facility in Taiwan to Bora Pharmaceuticals Co. Ltd. in a deal valued at $18.5 million.

* Harbin Gloria Pharmaceuticals Co., Ltd. will acquire a 70% stake in a Shanghai-based information technology firm for a tentative price of about 1.6 billion Chinese yuan, Reuters reported.

* Eyenovia Inc. filed for an IPO on the Nasdaq Capital Market of up to $35 million of its common stock.

* Pfizer Inc. completed the private offer to exchange its outstanding £1.5 billion 6.500% notes due 2038 with newly issued debt securities.

Drug and product pipeline

* Shire plc said the phase 2/3 trial of SHP609 in children with Hunter syndrome and cognitive impairment failed to meet its main and secondary goals.

* UCB SA said its phase 2b study of bimekizumab in psoriatic arthritis met its main goal.

* The U.S. FDA accepted Samsung Bioepis Co. Ltd.'s biologics license application for its biosimilar version of Roche Holding AG's breast cancer drug Herceptin. If approved, SB3 will be commercialized in the U.S. by Merck & Co. Inc.

* The European Medicines Agency's Committee for Medicinal Products for Human Use requested the Scientific Advisory Group on Oncology to provide an opinion on aspects of the ongoing marketing authorization application relating to a potential conditional approval for Clovis Oncology Inc.'s ovarian cancer drug Rucaparib.

* The U.S. FDA approved Exelixis Inc.'s Cabometyx tablets for the expanded indication of patients with advanced renal cell carcinoma, the most common form of kidney cancer in adults.

* Medicure Inc. said the FDA approved Carmel Biosciences Inc.'s cardiovascular drug Prexxartan, the first and only approved oral liquid dosage form of the angiotensin II receptor blocker valsartan in the U.S.

Operational activity

* France's competition regulator imposed a €25 million fine on Johnson & Johnson for blocking generic competition to the company's opioid painkiller Durogesic, Reuters reported.

* Pfizer and Array BioPharma Inc. entered into a clinical trial collaboration agreement to study the combination of several cancer immunotherapies, including Array's binimetinib with Pfizer's investigational talazoparib and Bavencio, or avelumab.

* Roche secured an option to exclusively develop and market Idorsia Ltd.'s oncology compounds as part of a research collaboration. Roche will pay Idorsia an upfront payment of CHF15 million and up to CHF35 million in further payments.

* Celltrion, Inc. sold the license to its biosimilar drug Truxima to Hikma Pharmaceuticals PLC covering the Middle East and North Africa region. Truxima is a biosimilar version of Roche's MabThera, or rituximab, which is approved in Europe for treating non-Hodgkin lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis, among others.

* Biogen Inc. and Ionis Pharmaceuticals Inc. signed a collaboration agreement to identify new antisense oligonucleotide drug candidates to treat spinal muscular atrophy. Ionis will receive a $25 million upfront payment and could earn development and regulatory milestone payments from Biogen.

* Teva Pharmaceutical Industries Ltd. CEO Kare Schultz rejected Israeli Prime Minister Benjamin Netanyahu's request to keep open the company's manufacturing plant in Jerusalem, Bloomberg News reported, citing a company statement. The company plans to close the manufacturing site, which employs roughly 800 people, by the end of 2019, as part of a restructuring plan.

Our features

Allergan, Celgene among analysts' favorite pharma stocks heading into 2018: Allergan plc, Celgene Corp. and Biogen have the most favorable recommendations from analysts among the top 20 drugmakers globally, while Sanofi and GlaxoSmithKline have the least favorable consensus scores.

Other features

* The Journal highlights the recent surge of deals in healthcare companies and how they signal the shift of medical service providers from hospitals to clinics, surgery centers and drugstores.

The day ahead

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

In Asia, the Hang Seng fell 0.07% to 29,234.09, and the Nikkei 225 was up 0.10% to 22,891.72.

In Europe, as of midday, the FTSE 100 was down 0.12% to 7,535.33, and the Euronext 100 had fallen 0.39% to 1,041.90.

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