Top news
* The U.S. Food and Drug Administration approved Pfizer Inc.'s Abrilada, a biosimilar to AbbVie Inc.'s blockbuster drug Humira, to treat certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.
* Recipharm AB (publ) is acquiring Consort Medical PLC for 1,010 pence in cash. The deal values the entire issued and to be issued ordinary share capital of Consort at about £505 million on a fully diluted basis and implies an enterprise value of £627 million.
* Alkermes PLC agreed to acquire privately held biopharmaceutical company Rodin Therapeutics Inc. for an up-front cash payment of $100 million. Rodin's security holders will be eligible to receive future payments of up to $850 million if Rodin's development candidates achieve certain clinical and regulatory milestones.
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* Biogen Inc. and Eisai Co. Ltd. surprising turnaround decision to continue seeking U.S. approval for their Alzheimer's disease drug aducanumab has some experts optimistic, while others still wonder if the trial results will be enough to clear regulatory scrutiny.
* A large, federally-funded study suggests that invasive heart procedures to implant stents or perform coronary artery bypass are not necessarily better than drug treatment and improved lifestyle decisions in preventing heart attacks and deaths among patients with chronic, or stable, coronary artery disease, The Wall Street Journal reported.
* Lab results related to finding whether asbestos was present in Johnson & Johnson's baby powder were more complicated than previously thought, the Journal reported. In October, J&J said that independent testing had found no asbestos in a bottle of baby powder that was retested since the U.S. FDA found trace amounts of the cancer-causing mineral in a sample. However, J&J's push for a rapid outcome contributed to results that were more complicated, said the report.
* South Korea's biotechnology sector has lost almost half its market since early 2018, as short sellers highlighted bubble fears linked to the industry, the Financial Times reported.
On the policy front
* Stephen Hahn, President Donald Trump's nominee to lead the U.S. FDA, made the rounds on Capitol Hill last week to gain some insight into — and possibly get some coaching to address — the questions senators may ask him at his Nov. 20 Senate confirmation hearing. One key question that may come up for Hahn at his confirmation hearing is whether he supports the Right to Try Act, which allows critically ill patients to sidestep the FDA in seeking access to experimental therapies.
* Four national hospital groups have vowed to challenge the Trump administration's finalized price transparency rule in court. The hospital representatives said that the finalized rule, which requires hospitals to make prices privately negotiated with insurance companies public, exceeds the administration's authority and will increase prices.
M&A and capital markets
* Bristol-Myers Squibb Co.'s $95 billion acquisition of Celgene Corp. has cleared all remaining regulatory hurdles with the U.S. Federal Trade Commission's approval and the required divestiture of the psoriasis drug Otezla. Bristol-Myers said late Nov. 15 that the FTC approval means the megadeal is on course for a Nov. 20 closure.
* Roche Holding AG is acquiring privately held Promedior, Inc. for $390 million, adding another pipeline product to the Swiss pharmaceutical giant's lung portfolio. Roche will also make additional payments of up to $1 billion to Promedior upon the completion of certain development, regulatory and commercial milestones.
* Aerie Pharmaceuticals Inc. agreed to acquire Avizorex Pharma SL, a Spanish company developing therapies for drug eye disease. Aerie will make an up-front payment of $10 million, with AVX Pharma shareholders eligible to receive additional payments based on certain milestones and sales royalties.
* Israel-based Taro Pharmaceutical Industries Ltd. said it began a tender offer to buy back up to $225 million worth of its ordinary shares.
Drug and product pipeline
* Merck & Co. Inc. and Bayer AG said their investigational drug vericiguat helped reduce the risk of hospitalization or death in certain patients with heart failure when given in combination with available heart failure therapies, thus meeting the main effectiveness goal of a late-stage study.
* The U.S. FDA approved Novartis AG's medicine Adakveo to reduce the frequency of pain crises in certain patients with a type of blood disorder called sickle cell disease.
* Karuna Therapeutics Inc. said KarXT was shown to be effective in treating acute psychosis in patients with schizophrenia — meeting the main goal of a phase 2 study, which compared the therapy to placebo and used the positive and negative syndrome scale.
* Shares of resTORbio Inc. tumbled by about 84% on Nov. 15 after the company reported that its medicine RTB101 failed to reduce respiratory tract infections during the winter cold and flu season in a phase 3 trial. The Boston-based company will halt the development of the therapy in this indication.
* Anchiano Therapeutics Ltd.'s stock fell by about 35% after the company reported that it will discontinue developing its experimental bladder cancer gene therapy BC-819. The company said that an analysis of data from a phase 2 trial showed that the treatment was unlikely to meet the prespecified efficacy threshold.
Operational activity
* Novo Nordisk A/S and Dicerna Pharmaceuticals Inc. signed an agreement to discover and develop therapies for liver-related cardio-metabolic diseases using Dicerna's proprietary GalXC RNAi platform technology. Novo Nordisk will pay $175 million up front and will also make a $50 million equity investment in Dicerna. Dicerna is eligible to receive an additional $75 million over three years, plus up to $357.5 million per target in potential milestone payments, sales and royalties.
* Vertex Pharmaceuticals Inc. is collaborating with Molecular Templates Inc. to discover novel targeted therapies that may enhance blood-related stem cell transplant process. Vertex will make an up-front payment of $38 million to Molecular Templates, including an equity investment. Molecular Templates is also eligible to receive future development, regulatory and sales milestones, and option payments of up to $522 million, as well as royalty payments based on sales.
* CSPC Pharmaceutical Group Ltd. said its nine-month profit rose 24% year over year. The Hong Kong-listed company's profit attributable to shareholders was 2.81 billion Chinese yuan, up from 2.27 billion yuan from the year-ago period.
* An Oklahoma district court judge reduced a fine to be paid by Johnson & Johnson in the ongoing opioid litigation to $465 million due to a numerical error. Judge Thad Balkman of the District Court of Cleveland County ordered the pharmaceutical giant in August to pay $572 million to abate damages caused by the opioid crisis — an epidemic that kills 130 Americans each day.
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng rose 1.35% to 26,681.09, while the Nikkei 225 advanced 0.49% to 23,416.76.
In Europe, around midday, the FTSE 100 was up 0.29% to 7,324.06, and the Euronext 100 was down 0.04% to 1,133.58.
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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