LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay receives Emergency Use Authorization from the FDA along with being successfully validated by the UK Health Security Agency (UKHSA) under the Coronavirus Test Device Approvals (CTDA) process.
This multiplex test utilizes the innovative qSTAR technology allowing for high-throughput, direct amplification, with highly sensitive results on open molecular platforms.
LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay adds to LumiraDx’s expanding portfolio of qSTAR molecular solutions for COVID testing.
Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), a medical technology company focused on saving lives by making an ECG (also known as an EKG) a far more valuable screening tool through the use of Artificial Intelligence (AI), today announced it has been granted a patent in Israel (Patent No. 10-2490960) from the Israel Patent Office.
RedHill Biopharma Ltd.(NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the extinguishment of all RedHill's debt obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement between RedHill's U.S. subsidiary RedHill Biopharma Inc. and HCR datedFebruary 23, 2020(as amended) in exchange for the transfer of its rights in Movantik®(naloxegol) to Movantik Acquisition Co., an affiliate of HealthCare Royalty ("HCR").
HCR will assume substantially all post-closing liabilities, and RedHill will retain substantially all pre-closing liabilities relating to Movantik.
As part of the parties' arrangement, and to ensure continuous patient care, RedHill will provide HCR with paid transition services for up to 12 months.
HCR will retain security interests in certain RedHill assets until substantially all pre-closing liabilities relating to Movantik have been paid or other specific conditions are met.
Tonix Pharmaceuticals, Inc. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 2 ‘PREVENTION’ study of TNX-1900 (intranasal potentiated oxytocin) for the prevention of migraine headache in chronic migraineurs.
The double-blind, placebo-controlled study has a target enrollment of 300 participants at approximately 25 sites across the U.S. Results from a planned interim analysis are expected to be released in the fourth quarter of 2023.
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD. The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023.
Pharmaceutical companies that made billions from the pandemic over the past two years selling vaccines and treatments are now up against a steep COVID cliff and investor pressure to spend their windfalls wisely.
Western drugmakers including Pfizer Inc, BioNTech SE, Moderna Inc, Gilead Sciences Inc, AstraZeneca Plc and Merck & Co are estimated to have brought in about $100 billion in revenue from COVID vaccines and treatments in 2022.
Company and analyst estimates suggest those sales could fall by nearly two-thirds this year due to built up product inventories around the world including in the countries that pay the most. Population immunity from high rates of vaccination and previous infections means that demand for treatments could dip as well.
These companies are used to steep revenue drops known as patent cliffs that occur when their exclusivities on big-selling drugs expire and generic rivals move in, but they strategize for those swings for years.
"When you think about traditional drug and vaccine development and longevity of sales, it's usually much more spread out," Morningstar analyst Damien Conover said. "This is very, very concentrated."
The sudden inflow of revenue should prod companies to strike deals and link up with new partners, he said. BMO Capital Markets analyst Evan Seigerman said companies should use the quick cash for transformative deals.
"Pfizer did these $10 billion deals to build their portfolio and I think they need to do something bigger and more impactful," he said, referring to the $5.4 billion buyout of Global Blood Therapeutics and $11.6 billion purchase of migraine drugmaker Biohaven Pharmaceutical.
Pfizer has been the biggest corporate beneficiary of the pandemic financially, with more than $56 billion in 2022 revenue from the vaccine it developed with German partner BioNTech and from its COVID-19 antiviral treatment Paxlovid.
Pfizer has said it expects that revenue to drop to around $21.5 billion in 2023, although some analysts believe that forecast is overly optimistic.
"We remain skeptical that COVID revenues will grow in 2024 and beyond," JP Morgan analyst Chris Schott said in a research note, adding that vaccination rates could fall even further than the significant decline seen with booster shots in 2022.
A woman receives a booster dose of Pfizer-BioNTech vaccine against the coronavirus disease (COVID-19), ahead of brace of an influx of Chinese tourists as COVID restriction are dismantled, at the Police hospital in Bangkok, Thailand, January 5, 2023. REUTERS/Athit Perawongmetha
Vaccine maker Moderna also expects 2023 revenue to fall sharply. The company's only product - its messenger RNA COVID vaccine - pulled in around $18.4 billion in 2022. Analysts expect that to drop to around $7 billion in 2023. The company is due to report earnings later this month.
Oppenheimer & Co analyst Hartaj Singh said investors are "frustrated Moderna hasn't used their firepower more effectively to prepare for revenues and earnings going down in 2023 or 2024."
Moderna shares are up in recent months, but a $173.25 closing price on Friday is more than 65% off their pandemic high of close to $500 in August 2021.
"There are examples of companies that have sat on their hands and the share price has not done well, and Moderna could go down that path," Singh cautioned.
MERCK, LILLY PLAN FOR DECLINE
Other companies have seen a more modest impact from their COVID businesses.
"We are not counting on Lagevrio as a driver of growth for our business," Merck Chief Executive Rob Davis said in an interview last week of the company's antiviral pill. "We very much saw Lagevrio as an opportunity to make a meaningful difference at a time of need."
Merck reported sales of $5.7 billion from the treatment last year. Analysts expect that to drop below $1 billion this year. Merck had over $59 billion in total sales in 2022.
Eli Lilly and Co made $2 billion in 2022 from monoclonal antibody COVID treatments and is not expecting any revenue from the business in 2023.
The U.S. Food and Drug Administration pulled its authorization of Lilly's latest antibody bebtelovimab in November because it was not effective against circulating Omicron subvariants.
"We did fine with COVID," Eli Lilly CEO Dave Ricks said in an interview. "We made a little bit of money with it. What we did with that was we mostly reinvested it in R&D (Research and Development), and last year was a record R&D spending year for the company."
The Department of Justice’s Antitrust Division has withdrawn three “outdated” policy statements on antitrust enforcement in healthcare, according to a Friday notice.
The statements initially released in 1993, 1996 and 2011 outlined circumstances in which the DOJ and Federal Trade Commission would or would not challenge transactions related to hospitals and physicians’ groups.
Alongside mergers, the statements also addressed provider joint ventures, joint purchasing arrangements, information provision to purchasers, participation in information exchanges and accountable care organizations’ participation in the Medicare Shared Savings Program.
Policy statements and guidance documents such as these are non-binding and are intended to give market players a better look into regulators’ priorities as they review deal proposals.
In the announcement, DOJ said that its recent enforcement actions and advocacy for competition in healthcare are sufficient and timely guidance for the public. Moving past the broader guidelines will also allow the agency to weigh healthcare deals’ competitive impacts on a case-by-case basis, DOJ said.
“The healthcare industry has changed a lot since 1993, and the withdrawal of that era’s out of date guidance is long overdue,” Assistant Attorney General Jonathan Kanter of the Justice Department's Antitrust Division said in a release. “The Antitrust Division will continue to work to ensure that its enforcement efforts reflect modern market realities.”
The withdrawn guidances had become “overly permissive on certain subjects, such as information sharing,” with the passage of time, DOJ wrote, and no longer serve their intended purposes of providing encompassing guidance to the public.”
Justin Bernick, a partner at Hogan Lovells who defends clients in antitrust lawsuits, said that the DOJ’s withdrawals were “abrupt” and “unfortunate” for healthcare players trying to get a bead on regulatory enforcement.
“[DOJ’s decision] continues the trend of the agencies straying further from established—and appropriate—precedent that companies, including companies outside the healthcare industry, have relied upon for decades,” Bernick wrote in an email statement. “In particular, the safe harbor for aggregating data across companies clearly is not ‘outdated.’ It is more important than ever not to disincentivize the procompetitive benchmarking, data analytics and consumer transparency tools, for example, that help drive efficiency and innovation in the modern healthcare economy and across industries.”
Federal regulators have broadly signaled their interest in cracking down on consolidation and other anticompetitive practices in healthcare. Recent years have seen a handful of hospital deals either blocked or opposed by government agencies, though DOJ had a bit more trouble in the payer space with last year’s UnitedHealth Group-Change Healthcare deal.
