Pfizer defends vaccine after doctor's death; EU OKs Viiv's HIV drug for infants

TOP NEWS IN HEALTHCARE

* A Florida doctor who received one dose of Pfizer Inc. and BioNTech SE's COVID-19 vaccine Comirnaty has died, although the company said in a Jan. 12 statement that the death was not connected to the inoculation. "We are actively investigating this case, but we don't believe at this time that there is any direct connection to the vaccine," a Pfizer spokesperson said in an email to S&P Global Market Intelligence.

* The European Commission granted marketing authorization to ViiV Healthcare Ltd.'s Tivicay tablets to treat HIV-1 infection in children aged at least four weeks and weighing at least 3 kilograms. Globally, there are about 1.7 million children living with HIV, and about 100,000 children are dying each year from AIDS.

➤ Azar deviates from CDC vaccination groups, adopts Biden plan to release reserve

The Trump administration in its last days made changes to its COVID-19 vaccination program, including releasing the reserve of doses that were being held back for second shots, a strategy President-elect Joe Biden said he planned to use.

➤ Top drugmakers flagged by US drug pricing watchdog for unsupported price hikes

AbbVie Inc., Amgen Inc. and other major pharmaceutical companies have been flagged by the Institute for Clinical and Economic Review for raising prices on major drugs without evidence to support the changes.

➤ CVS will distribute 20-25 million COVID-19 vaccines per month – executives

Incoming CEO Karen Lynch said the company has already administered over 700,000 in long-term care facilities, but in CVS' own stores, they want to be able to administer nearly 1 million vaccines per day.

PHARMACEUTICALS

* Sanofi's $1.1 billion acquisition of U.K. antibody-drug developer Kymab Ltd. is a step toward the French company becoming a leader in immunology, CEO Paul Hudson said.

* Data from COVID-19 vaccine and drug developers that was hacked in early December has been leaked online, according to the European Medicines Agency. Cybercriminals accessed documents related to COVID-19 medicines and vaccines belonging to third parties, including Pfizer and its German partner BioNTech.

* Johnson & Johnson is opposing its talc supplier Imerys Talc America Inc.'s bankruptcy replacement plan, claiming that such a move will only immunize its French parent Imerys SA while leaving the New Brunswick, N.J.-based pharmaceutical giant more vulnerable to lawsuits, The Wall Street Journal reported.

* Bayer AG's three new drugs with the potential to be blockbusters will not be able to compensate for the revenue drop when blood thinner Xarelto and eye medicine Eylea — two of the German healthcare conglomerate's best-selling products — lose patent exclusivity, the Financial Times wrote, citing Head of Pharmaceutical Division Stefan Oelrich.

* In a joint statement, main pharmaceutical lobby groups in the U.S. and Europe recommended adhering to the vaccine dosing and schedules tested in clinical studies, noting that any amendment "should follow the science and be based on a transparent deliberation of the available data."

* Health experts in Australia are urging the government to reassess its vaccine strategy amid concerns that the COVID-19 shot developed by AstraZeneca PLC and Oxford University does not have enough efficacy to induce herd immunity, the Financial Times said.

* India's Cadila Healthcare Ltd. expects to deliver 100 million to 150 million doses of its COVID-19 vaccine candidate ZyCoV-D by the end of 2021, the drugmaker said in a stock exchange filing.

BIOTECHNOLOGY

* Latest results of a Brazilian study evaluating Beijing-based Sinovac Biotech Ltd.'s CoronaVac found that the vaccine was only 50.4% effective in preventing asymptomatic COVID-19 infection, lower than the previously touted 78% efficacy against mild-to-severe COVID-19 cases, Reuters reported, citing São Paulo's Butantan Institute.

Meanwhile, a unit of the Chinese drugmaker could double its yearly production capacity of CoronaVac to 1 billion doses by February, another Reuters report said, citing a news conference with Sinovac Chairman Yin Weidong.

* Switzerland's drug regulator Swissmedic authorized Cambridge, Mass.-based Moderna Inc.'s COVID-19 vaccine mRNA-1273 after completing its review.

* The U.S. government agreed to purchase up to 1.25 million additional doses of Regeneron Pharmaceuticals Inc.'s COVID-19 antibody cocktail, bringing the total potential purchase to over 1.5 million doses.

* Misgav, Israel-based Biond Biologics Ltd. is collaborating with French pharmaceutical company Sanofi to develop and commercialize its experimental antibody BND-22 for solid tumors. Under the deal, Biond will receive an up-front fee of $125 million in cash and may receive more than $1 billion in milestone payments, as well as royalty payments.

* San Diego-based La Jolla Pharmaceutical Co. granted Germany's Paion AG the rights to market its drugs Giapreza and Xerava in the European Economic Area, the U.K. and Switzerland, for an up-front cash payment of $22.5 million and up to $109.5 million in milestone payments.

HEALTHCARE EQUIPMENT

* Abbott Park, Ill.-based Abbott Laboratories is set to complete the U.S. government's order for 150 million BinaxNOW COVID-19 Ag Card rapid tests in the second week of January.

MARKETS

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