December 2020 - February 2021
Israel to Share Data with Pfizer in Exchange for COVID-19 Vaccine Doses
Israel has committed to send Pfizer statistical data and details in exchange for COVID-19
Israel has committed to send Pfizer statistical data and details in exchange for COVID-19 vaccine doses. Pfizer will send Israel a weekly consignment of between 100,000 and 500,000 vaccine doses, with more than a million doses set to be provided by the middle of March. In return, Pfizer will receive anonymized data about consequences of the inoculations, side effects, efficacy, and the amount of time it takes to develop antibodies,
according to different types of population, age, gender, pre-existing conditions, and other factors. Israel’s Ministry of Health has also secured six million doses of the Moderna COVID vaccine. Results from this huge research will serve to set vaccination strategies in the rest of the world and assist pharmaceutical companies in continuing R&D for coronavirus vaccinations and other treatments. Data will also be shared with the World Health Organization (WHO).
FDA Clears Lilly’s COVID-19 Antibody Cocktail for Emergency Use
Eli Lilly & Co.’s combination antibody drug for COVID-19 was cleared for emergency use by U.S. regulators, providing doctors with a treatment option that is expected to be better able to combat new coronavirus mutations. The Food and Drug Administration authorized the treatment for use in COVID-positive adults and children 12 and older who are at high risk of developing severe forms of the disease or progressing to the hospital. The combo treatment is the second antibody therapy from the Indianapolis-based drugmaker to gain an emergency authorization from the FDA. In November, the agency cleared bamlanivimab, one of the two antibodies used in the cocktail, for use in non-hospitalized, high-risk patients with mild-to-moderate symptoms of COVID-19.
J&J Asks FDA for Emergency Clearance of Coronavirus Vaccine
Johnson & Johnson (J&J) has applied to the FDA seeking Emergency Use Authorization (EUA) for the single-dose COVID-19 vaccine candidate developed by the company’s Janssen Pharmaceutical. The FDA scheduled for February 26 a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider the Janssen COVID-19 vaccine candidate. J&J said its EUA will be based on topline efficacy and
safety data from the nearly 44,000-patient Phase III trial. According to that data, the vaccine was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.
Celgene’s Cell Therapy Spinout Nets $292M from Blank-Check Merger
Cell therapy developer Celularity is raising a total of $372 million, and announced a merger with a blank-check acquisition company and a separate financing from selling shares to institutional investors. The merger with GX Acquisition is the latest in a series of biotech deals with SPACs, or “special purpose acquisition companies,” which provide a streamlined route to public equity markets. Celularity spun out from Celgene in 2017 to develop
off-the-shelf therapies derived from cells in human placental tissue. The company is planning on initiating trials in 2021 of three experimental treatments for solid and blood cancers. The deal continues a trend of SPAC acquisitions that kicked off 2020. Nuvation Bio, Cerevel Therapeutics and Immatics all went public through these transactions, which surged 250% in the biotech sector in 2020, according to analysis firm Global Data.
McKinsey Settles for Nearly $600 Million over Role in Opioid Crisis
McKinsey & Company, the consultant to blue-chip corporations and governments around the world, has agreed to pay nearly $600 million to settle investigations into its role in helping “turbocharge” opioid sales, a rare instance of it being held publicly accountable for its work with clients. The settlements come after lawsuits unearthed a trove of documents showing how McKinsey worked to drive sales of Purdue Pharma’s OxyContin painkiller amid an opioid crisis in the United States that has contributed to the deaths of more than 450,000
people over the past two decades. McKinsey’s extensive work with Purdue included advising it to focus on selling lucrative high-dose pills, the records show, even after Purdue Pharma pleaded guilty in 2007 to federal criminal charges that it had misled doctors and regulators about OxyContin’s risks.
Abbvie, Biogen Lead Pharma in New Year’s Drug Price Hikes
AbbVie raised the list prices of many of its drugs on Jan. 1, while Biogen hiked the price tag of its old multiple sclerosis treatment Tysabri, part of broad, sector-wide increases typically taken at the start of a new year. The hikes could feature in calls for drug pricing legislation as a new Congress and new administration begin work. About 70 drugmakers raised prices to open 2021, averaging around 3.3%, lower than the average boost of 5.8% at the beginning of 2020, according to an analysis by RX Savings Solutions. The effect on prices seen by consumers is likely to be more limited, however, since insurers negotiate discounts off list prices. In his campaign, president-elect Joseph Biden endorsed controlling drug prices by allowing Medicare to negotiate directly with drug companies, something the program is barred from doing now. Congress is likely to begin debating such a plan once again, along with alternative proposals like imposing rebates on drugs when price
increases outpace inflation.
Health-Tech Funding Breaks Another Record in 2020
Healthcare technology companies brought in record levels of funding for 2020. Health-tech startups raised a total of $15.3 billion in 2020, up from $10.6 billion in 2019. With a total of 614 deals, for the first time, healthcare technology surpassed biopharma for deal volume. With the COVID-19 pandemic, healthcare investment across the board reached record levels, but digital health companies in particular were thrust into the spotlight, as
practices needed support communicating with patients, pharmaceutical companies launched virtual clinical trials and many people tried out telehealth visits for the first time. More companies are turning toward hybrid care models, pairing virtual services with in-person clinics.