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Philippines probes Sanofi dengue vaccine; China approves Lundbeck antidepressant


Essential IR Insights Newsletter Fall - 2023

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Philippines probes Sanofi dengue vaccine; China approves Lundbeck antidepressant

Top news

* The Philippines government launched a probe into the immunization of more than 730,000 children who received Sanofi's dengue vaccine, Dengvaxia, after the French drugmaker revealed it could worsen the disease in people not previously infected.

* H. Lundbeck A/S said the China Food and Drug Administration approved its antidepressant Brintellix. The company plans to launch the drug in the second quarter of 2018.

On the policy front

* Republicans dealt a blow to the Affordable Care Act as the Senate passed the Tax Cuts and Jobs Act in a 51-49 vote. The tax reform bill includes a provision to repeal the ACA's individual mandate, which requires all Americans who meet certain criteria to obtain health insurance for themselves and their families or pay a tax penalty.

Drug and product pipeline

* Bayer AG and Loxo Oncology Inc. said their cancer treatment larotrectinib had a 93% overall response rate in 17 pediatric patients with tropomyosin receptor kinase, or TRK, fusion cancers in a pediatric phase 1 trial.

* The U.S. Food and Drug Administration approved Amgen Inc.'s Repatha as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with cardiovascular disease.

* Sanofi discontinued the development of its experimental Clostridium difficile vaccine based on an analysis by an independent data monitoring committee. The committee concluded that the probability of the vaccine meeting its main goal in a phase 3 trial was low.

Operational activity

* Johnson & Johnson exercised its option to enter into a collaboration agreement with Idorsia Ltd. to jointly develop and commercialize ACT-132577, or aprocitentan, and any of its derivative compounds or products. Swiss biopharmaceutical company Idorsia said it will receive a one-time milestone payment of $230 million, which will be reflected in its fourth-quarter earnings.

* A life sciences fund based in the U.S. is considering investing up to $1 billion for the creation of a biotech company in the U.K., the Financial Times reported.

* Alliance Pharma plc agreed to acquire the rights to Vamousse from TyraTech Inc. for an initial consideration of $13 million. The assets comprise products for the prevention and treatment of human head lice.

Our features

Capitol Checkup: Biopharmas debate patent system, industry image, pricing cures: Even though the Trump administration is filling up with officials who appear to be friendly to the biopharmaceutical industry, that circumstance is unlikely to cure the sector's image problem, CEOs from some of the top drug companies acknowledged.

Other features

* The Financial Times carries a feature on counterfeit drugs and the efforts by big pharma companies, including Sanofi and Pfizer Inc., to counter them. According to the World Health Organization, fake medicines account for about $200 billion in global pharmaceutical revenues, or 10% to 15% of the total market worldwide.

* International pharmaceutical companies, including Johnson & Johnson and AstraZeneca PLC expressed their worry regarding regulatory challenges and additional costs as the U.K. exits the EU, Bloomberg News reported.

The day ahead

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

In Asia, the Hang Seng was up 0.22% to 29,138.28. The Nikkei 225 slid 0.49% to 22,707.16.

In Europe as of midday, the FTSE 100 added 0.53% to 7,338.92, and the Euronext 100 was up 1.04% to 1,041.13.

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