* Eli Lilly and Co. will offer half-priced versions of its two branded insulin products, Humalog Mix75/25 KwikPen and Humalog Junior, beginning mid-April. The cost-effective insulins, which are identical molecules to the branded products, will have a list price of $265.20 for one pack of five KwikPens.
* U.K.'s National Institute for Health and Care Excellence recommended AstraZeneca PLC and Merck & Co. Inc.'s Lynparza for treating adults who have relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer with a mutation in their BRCA1 or BRCA2 genes. The cancer therapy will be available for routine use in England's National Health Service for patients who were previously treated with three or more courses of platinum-based chemotherapy.
Meanwhile, the British drug price watchdog issued draft guidance rejecting Merck & Co.'s Keytruda for untreated head and neck squamous cell carcinoma that has spread to other parts of the body or cannot be removed through surgery and keeps coming back. NICE has asked Merck & Co. to provide more evidence demonstrating the drug's clinical and cost-effectiveness. Another drug to receive a no from NICE was Astellas Pharma Inc.'s Xospata, intended to treat patients whose acute myeloid leukemia with the FLT3 mutation has either returned or is unresponsive to treatment. NICE said in addition to Xospata's uncertain long-term survival benefit, the treatment is not considered cost-effective.
* Roche Holding AG is planning to price its yet-to-be-approved oral spinal muscular atrophy medicine risdiplam at a lower rate than its two competitors, Biogen Inc.'s Spinraza and Novartis AG's controversial gene therapy Zolgensma, Reuters said, citing an interview with William Anderson, CEO of Roche Pharmaceuticals. The U.S. Food and Drug Administration is set to decide on risdiplam's approval by May 24.
* The World Health Organization warned hospitals worldwide that the new strain of coronavirus, which caused 41 cases of a pneumonia-like disease in Wuhan, China, could lead to a wider outbreak despite the limited human-to-human transmission so far, Reuters reported, citing the U.N. health agency. Health authorities in Wuhan reported one death from the illness, while a new patient was identified in Thailand on Jan. 8 — the first confirmed case detected outside China.
* Researchers of rare diseases face a number of challenges to develop drugs for conditions with few patients, less attention by pharmaceutical companies and complex gene mutations that are barely understood. This edition of First in Human explores emerging treatments for the rare diseases Friedreich's ataxia and ornithine transcarbamylase deficiency.
On the policy front
* Even though opioids have been the key focus in the past few years in the nation's battle to end the U.S. addiction crisis, other illicit drugs, primarily cocaine and methamphetamine, have reemerged and are driving many of the recent overdose deaths, public health officials said.
* The American Hospital Association, Association of American Medical Colleges and three hospitals filed a lawsuit in the U.S. District Court for the District of Columbia claiming that Centers for Medicare and Medicaid Services does not have the authority to make nearly $800 million in Medicare payment cuts for off-campus hospital provider-based departments.
M&A and capital markets
* Hong Kong will probably see a greater number of healthcare companies that are involved in a wide variety of therapeutic areas go public via its stock exchange in 2020 as the market matures, according to two bankers who spoke to S&P Global Market Intelligence on the condition of anonymity.
* The healthcare industry saw the largest surge in deal activity in the past five years with 2,184 businesses poised to change hands in 2019, according to data compiled by S&P Global Market Intelligence. The sector saw $334.67 billion in deal-making activity — nearly $10 billion more than 2018, but fell short of the highs of 2014 when the industry saw $342.27 billion in M&A transactions.
Drug and product pipeline
* Nektar Therapeutics decided to withdraw its application for oxycodegol, the company's opioid medication intended to treat chronic lower back pain, after the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted against its approval.
* NICE recommended a combination of Pfizer Inc.'s Ibrance and AstraZeneca's Faslodex for use in the U.K.'s Cancer Drugs Fund to treat certain patients with breast cancer who have undergone hormone therapy.
* A late-stage study showed that AbbVie Inc.'s Skyrizi bested Novartis' Cosentyx in clearing the skin of patients with moderate to severe plaque psoriasis after 52 weeks of treatment. Skyrizi is already approved in the U.S. and EU to treat adult patients with plaque psoriasis who are candidates for systemic therapy.
* Boston Scientific Corp.'s stock price fell by 6.17% to close at $42.67 at the close of markets Jan. 14 after the medical-device maker released preliminary fourth-quarter metrics that missed multiple estimates. Boston Scientific Chairman and CEO Michael Mahoney said the misses were a surprise, and the company nevertheless expects a strong 2020.
* Amgen Inc. estimates that about 25% of its growth will be driven by Asia over the next decade, Reuters said, citing an interview with CEO Robert Bradway.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng declined 0.39% to 28,773.59, and the Nikkei 225 fell 0.45% to 23,916.58.
In Europe, around midday, the FTSE 100 gained 0.10% to 7,629.13, and the Euronext 100 was essentially flat at 1,157.62.
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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