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Pfizer is near a deal to combine its off-patent drugs division — which includes best-selling treatments like Viagra — with Mylan, the maker of the EpiPen emergency allergy treatment, to create a new giant in the business of drugs without patent protections, two people briefed on the matter said. A deal could be announced as soon as Monday, according to these people, who were not authorized to speak publicly about the confidential discussions. (de la Merced and Thomas, 7/28)

The deal, which hasn’t been completed, could be announced as early as Monday if an agreement is reached, the people said. The companies have discussed a stock deal in which Mylan shareholders would own a little more than 40% of the new entity and Pfizer shareholders the remainder, one of the people said. Pfizer would also receive about $12 billion in proceeds from a new sale of debt, this person said. Mylan’s market value currently stands at just under $10 billion. (Rockoff and Lombardo, 7/29)

Michael Goettler, who runs Pfizer’s off-patent drug unit, would become chief executive of the combined company, and Mylan Chairman Robert Coury would be executive chairman, one of the people said. Current Mylan CEO Heather Bresch would depart. Mylan President Rajiv Malik, who faces civil suits accusing him of taking part in an alleged price-fixing scheme, would ultimately leave the combined company, one of the people said.(Annett and Griffin, 7/27)

Pharmaceutical behemoth Pfizer Inc. has transformed itself under new leadership through a series of spinouts and joint ventures, mitigating risk by placing some units at arm’s length while continuing to reap rewards from them. Chief Executive Officer Albert Bourla, 57, who took the helm in January after serving as the drugmaker’s operations chief, has rapidly transformed the company through a new deal-making strategy. His next major step may come as soon as Monday with a plan to combine Pfizer’s less-lucrative off-patent drug business with Mylan NV to form a generic-drug giant. (Griffin, 7/28)

The U.S. Food and Drug Administration is requiring that health warnings be added to Pfizer Inc. ’s drug Xeljanz, advising patients they could experience a higher risk of blood clots or death with a specific dose. The FDA’s warnings are specifically geared toward patients who take the 10-milligram dose of the medicine, known as tofacitinib, twice a day. The regulatory agency also said it is limiting the use of the treatment for ulcerative colitis so that patients can only take it if they have severe side effects from other medicines or aren’t treated effectively. (Prang, 7/26)

With investor interest in antibiotics dwindling, companies in the sector are crafting survival strategies that include seeking out alternative sources of funding and avoiding reliance on hospitals as customers. (Gormley, 7/26)

Last January, we compiled a list of “burning questions” for a group of the largest and most closely followed biotech companies. Answers to these questions — encompassing financial performance, clinical trial milestones, and regulatory approvals — can make or break a company’s performance during the year. August is almost here, so we figured it was a good opportunity to see how many of this year’s biotech burning questions have been answered, and what lies ahead. (Feuerstein and Garde, 7/29)