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US FDA furloughing more staff; Lilly cancer drug Lartruvo fails late-stage study


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US FDA furloughing more staff; Lilly cancer drug Lartruvo fails late-stage study

Top news

* U.S. Food and Drug Administration Commissioner Scott Gottlieb said he is sending more of his workers home during the government shutdown, adding to the more than 7,000 employees who were furloughed about four weeks ago. The commissioner said he is also halting FDA advisory committee meetings — public hearings where scientific experts discuss the efficacy and safety of experimental therapies and provide their recommendations for approval or evaluate the risks of certain products.

* Eli Lilly and Co. said a combination of Lartruvo and doxorubicin failed to improve survival compared to doxorubicin alone in a late-stage study in patients with soft tissue sarcoma. Lartruvo, which had received temporary FDA approval on the basis of a phase 2 study, was required to confirm its effectiveness in the phase 3 study. The company will stop promoting the drug and expect to incur a pretax charge of $70 million to $90 million in the first quarter of 2019.

* A panel of outside expert advisers to the FDA was split over whether the agency should grant approval to Sanofi and Lexicon Pharmaceuticals Inc. to market their experimental diabetes drug Zynquista.

On the policy front

* The Institute for Clinical and Economic Review will conduct an annual analysis of prescription drug price increases to determine whether those increases are supported by new evidence.

* Headwinds from the U.S. generics market and the opioid crisis are pushing certain healthcare companies to restructure and move away from such segments, Fitch Ratings said in a report.

M&A and capital markets

* Cancer immunotherapy developer INmune Bio Inc. priced its IPO of common shares to raise up to $20 million. La Jolla, Calif.-based INmune is offering up to a minimum 1 million shares and up to a maximum of 2.5 million shares at $8 apiece.

Drug and product pipeline

* The FDA is trying to make it easier for makers of the opioid reversal agent naloxone to sell their products without a prescription. The agency took the unprecedented step of creating a consumer-friendly drug facts label, which is required for companies to sell their products over the counter without a prescription.

* Morris Plains, N.J.-based Immunomedics Inc. said the U.S. Food and Drug Administration rejected sacituzumab govitecan as a treatment for an aggressive type of breast cancer.

* The U.K.'s National Institute for Health and Care Excellence recommended AbbVie Inc. and Roche Holding AG's Venclyxto in combination with Rituxan to treat adults with a type of blood and bone marrow cancer.

* NICE also recommended a combination of Array BioPharma Inc. and Pierre Fabre Medicament SA's Braftovi, or encorafenib, as well as Mektovi, or binimetinib, to treat patients with a certain type of skin cancer. The combination therapy will be used to treat patients with BRAF V600 mutation-positive melanoma that cannot be removed surgically or that has spread to other organs.

Operational activity

* Johnson & Johnson is collaborating with Apple Inc. on a research study to determine if their technologies can be used together for earlier diagnosis of abnormal heart rhythm.

* India's largest drugmaker Sun Pharmaceutical Industries Ltd.'s shares tanked following reports related to a whistleblower's complaint alleging questionable transactions between the Mumbai-based company and its co-promoter Sudhir Valia, Reuters reported.

* Celgene Corp. partnered with Kyn Therapeutics Inc. to develop new immuno-oncology therapies using the Boston-based Kyn's experimental programs. Summit, N.J.-based Celgene, which is being acquired by Bristol-Myers Squibb Co., will pay Kyn $80 million up front and also make an undisclosed equity investment in the company.

Our features

Merck & Co., Allergan lead analysts' top stock picks in biopharma into 2019: Merck & Co. Inc., Allergan PLC and Bayer Aktiengesellschaft have the most favorable recommendations from analysts among the top 20 drugmakers by market capitalization, while AbbVie has the least favorable consensus score, data compiled by S&P Global Market Intelligence showed.

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Pharmacy costs for generic medicines trended lower in Q4: The average aggregate per-unit price of generic prescription medicines retail pharmacies pay decreased during the fourth quarter of 2018.

Bristol-Myers could attract a takeover bid amid Celgene megadeal, analysts say: As Bristol-Myers Squibb moves to take over Celgene in a blockbuster $74 billion deal, some analysts are speculating that the parent company-to-be might find itself the subject of its own megadeal.

Other features

* Financial Times published a report on the new technologies that have become the focus of healthcare research and development sector.

* California-based Proteus Digital Health Inc. launched a sensor that can be combined with cancer drugs to help notify doctors after the patients have taken their medicines, Stat reported.

* The New York Times featured a report on the potential brain-related side effects of cannabis products.

The day ahead

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

In Asia, the Hang Seng increased 1.25% to 27,090.81, and the Nikkei 225 rose 1.29% to 20,666.07.

In Europe, around midday, the FTSE 100 was up 1.40% to 6,930.93, and the Euronext 100 was up 1.52% to 949.88.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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