* The Bill & Melinda Gates Foundation is committed up to $140 million in Intarcia Therapeutics Inc. as part of an effort to combat HIV. Intarcia Therapeutics is developing an anti-HIV vaccine that would be administered annually or semi-annually in sub-Saharan Africa and other countries where the epidemic is most severe.
* Johnson & Johnson is rumored to break up Actelion Ltd. in a proposed acquisition of the company. The deal would reportedly involve the separation of the Swiss biotechnology company's commercialized portfolio from its research and development assets, which would be placed in a new publicly traded company. Meanwhile, French drugmaker Sanofi is also in advanced talks to acquire Actelion.
* Pascal Soriot told London's Financial Times that U.K.'s lengthy drug approval process was costing patients with life-threatening diseases. The AstraZeneca PLC CEO said that prolonged negotiations between pharmaceutical companies and regulators for treatments that were otherwise approved in the U.S. and other parts of Europe delayed the time until patients gained access to the life-saving drugs.
M&A and capital markets
* Golden Meditech Holdings Ltd. is selling the entirety of its holdings in China Cord Blood to Nanjing Yingpeng Huikang Medical Industry Investment Partnership for 5.76 billion Chinese yuan in cash. The sale of the 65.4% stake will result in a "significant return to both the group and its shareholders," Golden Meditech said.
* Lpath Inc. merged into Apollo Endosurgery Inc., a medical device company focused on the treatment of obesity. The combined company will be known as Apollo Endosurgery and will trade on the Nasdaq Global Market under the symbol APEN.
* Mitsubishi Gas Chemical Co. Inc. plans to invest ¥30 billion in biotechnology and healthcare companies in an effort to diversify its business, Tokyo's The Nikkei reported.
* Eurofins Scientific SE agreed to acquire Villapharma Research SL in Spain as part of a plan to expand its footprint in discovery pharmacology. The transaction is expected to close in February 2017.
Drug and product pipeline
* The U.S. FDA withheld approval of Cempra Inc.'s Solithromycin for the treatment of community-acquired bacterial pneumonia in adults. The regulator said in a complete response letter that the available database of 920 patients was too small to fully characterize the potential risk of hepatotoxicity, or chemical-driven liver damage, in patients treated with the drug.
* Bavarian Nordic A/S initiated a phase 1 trial combining its cancer candidate CV301 with Bristol-Myers Squibb Co.'s Opdivo for patients with non-small cell lung cancer who have failed prior therapy. The primary endpoint of the study is overall survival in patients with said cancer type.
* Mylan NV's generic version of the Concerta attention deficit hyperactivity disorder treatment nabbed U.S. FDA approval. Janssen Pharmaceuticals manufactures Concerta. Meanwhile, Mylan also launched a generic version of Pfizer Inc.'s Cerebyx injection in the U.S. to treat certain types of seizures.
* In other news, the U.S. FDA rejected Innocoll Holdings PLC's application for Xaracoll, a post-surgical pain management drug candidate. The FDA indicated that the application was not sufficiently complete to permit a substantive review.
* TetraLogic Pharmaceuticals and its unit TetraLogic Research and Development Corp. sold two clinical-stage oncology programs to Medivir AB for $12 million cash and additional future milestone payments. TetraLogic will use the cash proceeds to redeem some of its outstanding debt as it prepares to delist from the Nasdaq Global Market.
* NFI Consumer Healthcare acquired worldwide rights to Prestige Brands Holdings Inc.'s over-the-counter pregnancy test kit. The terms of the deal were not disclosed.
* In other news, Shenzhen Salubris Pharmaceuticals Co. Ltd. set up a life and health technology related joint venture in Beijing, Reuters reported.
* Oncology Venture Sweden AB gained exclusive rights to Medical Prognosis Institute A/S' drug response prediction technology for a period of three years.
* Elekta AB (publ) entered a 13-year collaboration with Stockholm's County Council and New Karolinska Solna to advance radiation therapy for cancer patients. Elekta will exclusively equip the cancer center and radiation therapy departments of New Karolinska Solna and Södersjukhuset for an initial order of approximately 350 million Swedish kronor.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng rose 0.96% to 22,000.56, while the Nikkei 225 slid 0.16% to 19,114.37.
In Europe, around midday, the Euronext 100 was down 0.04% to 930.40.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.