The U.S. Food and Drug Administration approved Pfizer Inc’s oral drug, tafamidis, to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy, the U.S drugmaker said. Pfizer, which has touted tafamidis as a potential blockbuster product, set a list price of $225,000 a year for the medicine, which would be sold under the brand name Vyndaqel.It is the first approved medicine for the disease in the United States. Analysts are forecasting annual sales to exceed $1 billion in 2024, according to Refinitiv data.

Unadjusted earnings per share of $3.18 fell from the year-ago quarter’s $3.25. While revenue remained the same at $5.6 billion, expenses in the quarter increased +9% year-over-year to $3.1 billion. The company’s revenue from Blincyto, its first bi-specific antibody for the treatment of cancer, surged +41% year-over-year to $69 million.Sales of its highest selling drug, Enbrel, rose +4% to $1.15 billion. Research & Development (R&D) expenses increased +16% largely towards bolstering the company’s oncology programs, as indicated by Amgen. For the full-year 2019, Amgen projects a revenue range of $22 billion and $22.9 billion.

Merck first quarter earnings surpassed analysts’ estimates, thanks in large part to its success in lung cancer treatment. For the three months ending in March, the pharma company’s GAAP earnings came in at $1.12 per share, beating the Street consensus estimates by seven cents.  Merck’s total revenues surged +8% year-over-year to $10.8 billion, on the back of a +55% sales growth of Keytruda lung cancer treatment. CEO Ken Frazier highlighted investments in research and development as one of the factors behind Merck’s strong quarter. Looking ahead, Merck lifted its full-year 2019 revenue outlook to a range of $43.9 to $45.1 billion, while forecasting GAAP earnings to  range between $4.02 and $4.12 per share. The company also revealed a global restructuring plan - which includes closing plants and slashing jobs - that is expected to get completed by 2023.

Eli Lilly and Co. reported lower-than-expected sales for its top-selling diabetes drug, Trulicity, and cut its full-year revenue forecast. Due to pressure to lower prices, Eli Lilly agreed to offer a half-priced version of insulin injection Humalog earlier this year.The drugmaker is one of the three main global providers of insulin products.  Lilly said it now expects 2019 revenue to come in between $22.0 billion and $22.5 billion, lower than its prior forecast of $25.1 billion to $25.6 billion.

Bristol-Myers Squibb reported better-than-expected results for the first quarter of 2019 on the performance of its blood thinner drug, Eliquis. First-quarter 2019 earnings of $1.10 per share beat analyst estimates by one cent and surpassed the year-ago quarter’s earnings of $0.94. Total revenue of $5.92 billion beat expectations of $5.80 billion and increased 14% from $5.2 billion in the year-ago period.Continued strong sales of Opdivo and Eliquis contributed to the top line in the reported quarter.

Two drugmakers will pay nearly $125 million to resolve claims they used charities that help cover Medicare patients’ out-of-pocket drug costs as a way to pay kickbacks aimed at encouraging the use of their high-priced medications, the U.S. Justice Department. The department said Japan-based Astellas Pharma and Amgen Inc, the world’s largest biotech company, were the latest to settle claims stemming from an industry-wide probe of drugmakers’ financial support of patient assistance charities. Astellas will pay $100 million while Amgen will pay $24.75 million, the department said.Neither company admitted wrongdoing.

Drugmaker Biogen beat analysts' estimates for first-quarter on higher sales of its growth driver Spinraza. Net income attributable to the company rose 20 percent to $1.41 billion, in the quarter ended March 31. On an adjusted basis, the company earned $6.98 per share on revenue of $3.49 billion.Analysts had expected the company to earn $6.87 per share on revenue of $3.39 billion.

In a recent announcement, Novartis confirmed its acquisition of IFM Tre, a subsidiary of IFM Therapeutics LLC that specializes in developing anti-inflammatory medicines, especially the NLRP3 inflammasome.This latest acquisition will now add to the company’s immunomodulatory medicine portfolio. Valued at $1.575 billion, according to the terms of the deal, Novartis would pay $310 million upfront and then become eligible to pay for as much as $1.265 billion in milestone payments.  The acquisition is a significant move for Novartis, as it gives it full exposure to IFM Tre's portfolio of NLRP3 inhibitors. The NLRP3, the nucleotide-binding domain containing three pathway, is crucial to the body’s immune system and works as a warning sensor for pathogens signaling tissue damage and metabolic disorders. The acquisition is significant as it means gaining control over IFM Tre's molecules that can selectively suppress inflammation caused by the NLRP3 inflammasome, while allowing the

Novartis must face a U.S. government lawsuit accusing it of paying millions of dollars in kickbacks to doctors so they would prescribe its drugs, after a federal judge ruled in a decision released on Monday that the government had offered evidence of a "company-wide kickback scheme.District Judge Paul Gardephe in Manhattan also rejected the Swiss drugmaker's bid to keep key government evidence out of the case, and ruled that the government does not have to prove a direct "quid pro quo" agreement between Novartis and doctors for the company to be liable. The ruling means that, unless Novartis settles, the case is headed for trial.

AstraZeneca says it will pay up to $6.9 billion to work with Daiichi Sankyo Co Ltd on a new experimental treatment for breast cancer. Britain’s AstraZeneca plans to use some of the proceeds of a $3.5 billion share issue to fund the deal. Under the deal, AstraZeneca will make an upfront payment of $1.35 billion to Daiichi.They will share development and commercialization costs for the drug worldwide, with Daiichi retaining exclusive rights in Japan. AstraZeneca will also target patients with low levels of HER2, a much larger breast cancer subgroup with poor treatment options and the drug’s biggest market opportunity, as well as certain lung and gastric tumors.

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.