The U.S. Federal Trade Commission is seeking additional information from Bristol-Myers Squibb Co and Celgene Corp.The focus of their investigation is on the companies’ psoriasis treatments as part of its review of their planned merger, Bristol-Myers said. “The parties understand that the FTC’s review is focused on marketed and pipeline products for the treatment of psoriasis,” Bristol-Myers said in a filing. Celgene’s psoriasis drug Otezla brought $448 million in sales in the quarter ended Dec. 31. 

AstraZeneca plc says the European Commission (EC) has approved a label expansion of its diabetes drug, Forxiga. Forxiga can now be used along with insulin in patients with Type-1 diabetes and a Body Mass Index (BMI) of 27 or more when insulin alone has not been able to control blood sugar levels, the company said.  Farxiga or Forxiga, as the drug is known outside the United States, is one of AstraZeneca’s top ten drugs by sales.It generated $1.39 billion in 2018.

According to court documents released on Monday, the German pharmaceutical multinational, Bayer AG, and the American pharmaceutical major, Johnson & Johnson, have finally agreed to settle more than 25,000 U.S. lawsuits over their best-selling blood thinner Xarelto, for a total of $775 million. Although Bayer and J&J are yet to admit liability under the agreement, the settlement resolves all the pending U.S. lawsuits over Xarelto.Plaintiffs accused the companies of failing to sufficiently notify patients on the risk of uncontrolled bleeding. Bayer had jointly developed Xarelto with J&J’s Janssen Pharmaceuticals unit, which sells the blood clot preventer under a licensing agreement in the United States. Xarelto emerged as Bayer’s best-selling drug in 2018 and contributed 3.6 billion euros ($4.07 billion) in revenue to the German group’s pharmaceutical business.

Biogen Inc. and partner Eisai Co. Ltd are ending two late-stage trials of their experimental Alzheimer’s disease drug 'aducanumab,' a major setback in the quest to find a treatment for the disease and a blow to Biogen, which lost more than $18 billion of its value. The decision was based on a so-called futility analysis of aducanumab data by an independent monitoring committee that determined the trials had little hope of succeeding.

Merck & Co., Inc. says the European Medicines Agency (EMA) has approved the label expansion of its blockbuster PD-1 inhibitor, Keytruda (pembrolizumab).The drug has now been approved in combination with chemotherapy for the treatment of adult patients with metastatic squamous non-small cell lung cancer (NSCLC) — a difficult to treat lung cancer. The European approval was expected as the Committee for Medicinal Products for Human Use had recommended the same in February.

A California jury in Oakland has found the company guilty and has ordered it to pay $29 million to the victim. The company, on the other hand, has denied such allegations claiming that its products are checked by experts and numerous studies and tests have already proved that their products are free from any cancer causing substance.The company has lost a motion to appeal a verdict in Missouri that awarded more than $4 billion to 22 women who accused that the asbestos in the company’s talcum products is the reason for their ovarian cancer. Following the current lawsuit, shares of the company have fallen sharply.

A California jury on Wednesday ordered Johnson & Johnson to pay $29 million to a woman who had claimed asbestos in the company's talcum-powder-based products, including Johnson's Baby Powder, caused her mesothelioma. The verdict, is just the latest in which the company faces more than 13,000 talc-related lawsuits nationwide. J&J said it was disappointed with the verdict and would appeal, citing "serious procedural and evidentiary errors" in the course of the trial.

Japan’s Fujifilm Holdings Corp will buy a drugmaking business from U.S.-based Biogen Inc for about $890 million to try to bolster its healthcare business as growth at its legacy photocopy operations stagnates. Read more...

OxyContin maker Purdue Pharma LP and two other drugmakers on Friday lost a bid to delay a landmark trial set for May in a multibillion-dollar lawsuit by Oklahoma’s attorney general accusing them of helping fuel an opioid abuse and overdose epidemic in the state. Read more...

The U.S. Food and Drug Administration is approving Johnson & Johnson's nasal spray anti-depressant for people resistant to other treatments.The approval of nasal spray "esketamine" is the first new type of treatment for depression in more than 30 years and has raised hopes for its relatively fast action and ability to treat some otherwise unreachable patients. “Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, global head of J&J’s Janssen Research & Development. The treatment carries the FDA’s harshest warning telling users of the risk for sedation and difficulty with attention, judgment and thinking, abuse and misuse, and suicidal thoughts after administration of the drug.

The announcement comes after criticism about rising drug prices in the United States. U.S. senators last week questioned executives from major drug companies, calling their pricing practices “morally repugnant."  Lilly’s cheaper product will be called Insulin Lispro, while Humalog, which makes $3 billion in annual sales, will remain available for those wishing to access it through existing insurance plans. The cost of insulin for treating type 1 diabetes in the United States has nearly doubled over a five-year period, leading some patients to put their own health at risk by rationing the medication.

They are offering $22.50 per share, a premium of about 69% to Nightstar's value. “Ophthalmology is an emerging growth area for Biogen,” said Michel Vounatsos, Biogen’s chief executive officer.“Nightstar would accelerate our entry into ophthalmology by contributing two mid- to late-stage gene therapy assets.” Biogen said it plans to fund the acquisition through available cash.

A major shareholder is casting doubt around the pharmaceutical industry’s biggest-ever between Bristol-Myers Squibb Co.’s and Celgene Corp. Wellington Management Co., which manages about $1 trillion in assets, and is the second largest shareholder in of Bristol-Myers stock, said in a news release that it “does not believe that the Celgene transaction is an attractive path” for broadening Bristol-Myers’s business.The firm holds 7.7 percent of Bristol-Myers shares. “While we are very disappointed by the position of Wellington Management, we will continue our discussions with shareholders about this unique opportunity to create sustainable value,” Chief Executive Officer Giovanni Caforio said in the memo made public in a filing Thursday.

German drugs and lab supplies maker Merck has offered $5.9 billion, including debt, for Versum Materials, in a cash deal that tops an offer from U.S. rival Entegris, as both seek to boost their electrochemicals operations. Merck said it planned to buy Versum for $48 per share - or $5.2 billion excluding debt - for a premium of 16% to Tuesday's closing price and of 52% to the share price before Entegris' offer. Entegris announced a $4 billion all-stock deal in January.

Pharmaceutical industry executives testifying before Congress say quick fixes to lower drug prices could jeopardize future medical breakthroughs. Read more...

Johnson & Johnson has received subpoenas from the U.S. Justice Department and the Securities and Exchange Commission related to litigation involving alleged asbestos contamination in its signature Baby Powder product line. The company said it intends to “cooperate fully with these inquiries and will continue to defend the Company in the talc-related litigation.” The disclosure in Johnson & Johnson’s annual report on Wednesday is the first time that the company disclosed it had received subpoenas from federal agencies regarding its talc powder products. Johnson & Johnson faces lawsuits involving 13,000 plaintiffs who allege use of its talc products, including Baby Powder, caused cancer.

Bristol-Myers Squibb said that the European Commission approved Sprycel, in combination with chemotherapy for the treatment of pediatric patients with certain cancers or leukemia. This is the second pediatric leukemia indication for Sprycel in Europe. “We are proud that the approval by the European Commission brings children with Ph+ acute lymphoblastic leukemia a new treatment option, including a powder formulation developed as part of our commitment to addressing the unique needs of children with cancer,” said Fouad Namouni, M.D., head, oncology development, Bristol-Myers Squibb.

Johnson & Johnson is buying privately held Auris Health Inc. for $3.4 billion.Auris makes a robotic scope used in respiratory and lung cancer procedures and will allow J&J to gain access to devices that simplify difficult surgical procedures. “This acquisition will accelerate Johnson & Johnson’s entry into robotics with potential for growth and expansion into other interventional applications,” J&J said in a statement. J&J also said the acquisition would complement its purchase last year of Orthotaxy, a privately held developer of software-enabled robotic technology for surgery.

In a busy week for the pharma sector, drug giants Merck and Eli Lilly reported fourth-quarter results along with GlaxoSmithKline and Sanofi. Read more...

This stems from an administration proposal that would require drugmakers to show full prices of medicines in TV ads. Johnson & Johnson has taken up the call and will start stating prices with ads for blood thinner Xarelto by March.Big pharma generally opposes the idea, arguing that list prices are meaningless to most Americans because health plans often negotiate huge discounts with drugmakers and consumers usually pay only a portion of a lower price themselves.