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Pfizer Looks Past COVID With $43 Billion Deal for Cancer Drug Maker Seagen
Pfizer Inc. (PFE.N) struck a $43 billion deal for Seagen Inc. (SGEN.O) to add innovative targeted therapies to its portfolio of cancer treatments as it braces for a steep fall in COVID-19 product sales and stiff competition for some top sellers.
Monday’s deal, Pfizer’s biggest in a string of acquisitions following a once-in-a-lifetime cash windfall from its COVID-19 vaccine and pill, will add four approved cancer therapies with combined sales of nearly $2 billion in 2022.
Washington-based Seagen is a pioneer of antibody-drug conjugates, which work like “guided missiles” designed for a targeted destructive effect and spare healthy cells.
The deal helps Pfizer move into an area “that it is more protected from regulators, patent perspectives and market dynamics,” Chief Executive Officer Albert Bourla said in a conference call.
U.S. Sues Rite Aid for Missing Opioid Red Flags
The Justice Department on Monday filed a lawsuit against Rite Aid for allegedly violating the Controlled Substances Act, alleging that the company “knowingly filled unlawful prescriptions for controlled substances.”
In a statement, Attorney General Merrick Garland said the Department of Justice is “using every tool at our disposal” to hold Rite Aid accountable for contributing to the opioid epidemic.
Associate Attorney General Vanita Gupta said “Rite Aid’s pharmacists repeatedly filled prescriptions for controlled substances with obvious red flags, and Rite Aid intentionally deleted internal notes about suspicious prescribers. These practices opened the floodgates for millions of opioid pills and other controlled substances to flow illegally out of Rite Aid’s stores.”
In the complaint, The Justice Department alleges that from May 2014 to June 2019, Rite Aid filled thousands of unlawful combinations of prescriptions known as “the trinity” which included prescriptions for “excessive quantities of opioids, such as oxycodone and fentanyl.”
Moderna Shares Pop 7% After Cowen Upgrades Stock, Saying It ‘Will Be a Leader’ in RSV Vaccines
Moderna shares jumped by nearly 7% on Monday after TD Cowen upgraded the stock, saying the company will “be a leader” in the RSV vaccine market.
TD Cowen also highlighted Moderna’s other vaccine candidates for diseases like the flu, a pipeline that can help the company become “less reliant” on new COVID-19 waves. Shares closed at $147.90 apiece.
The upgrade comes as Moderna navigates its post-pandemic-era boom driven by its mRNA COVID vaccine. The company became a household name for its messenger RNA technology, which teaches human cells to produce a protein that initiates an immune response against a particular disease.
Cowen pointed to the company’s potential RSV vaccine, noting that key opinion leaders believe RSV will be a “three-player vaccine market” between Moderna and drugmakers Pfizer and GSK. The three companies are in a race to approve the world’s first vaccine against the respiratory syncytial virus, which infects the lungs and respiratory tract and usually causes mild, cold-like symptoms.
Novo Nordisk to Slash U.S. Insulin Prices, Following Move by Eli Lilly
Novo Nordisk (NOVOb.CO) said on Tuesday it would cut U.S. list prices for several insulin products by up to 75% next year, joining rival Eli Lilly and Co (LLY.N) as political pressure mounts to make these life-sustaining diabetes treatments more affordable.
The moves follow the passing of President Joe Biden‘s Inflation Reduction Act last year which capped insulin prices for Medicare recipients at $35 per month but does not include patients without insurance.
More Than 100 Families of Children With ADHD, Autism From Tylenol Are Pursuing Lawsuits
Johnson & Johnson, along with a number of major retailers nationwide, including Walmart, CVS and Walgreens, already face more than 100 lawsuits brought by families of children with ADHD or autism from Tylenol use during pregnancy, and the number of claims is expected to rise sharply over the coming months.
The litigation has emerged after a number of studies were published over the past several years, which warned of the highlighted link between autism and Tylenol, as well as attention deficit hyperactivity disorder (ADHD) and other developmental problems that may result from exposure to the active ingredient acetaminophen before birth.
Each of the complaints raises similar allegations, indicating that makers of both name-brand Tylenol, store-brands and generic acetaminophen products failed to adequately warn women about the risks associated with taking the medications during pregnancy, which has previously been promoted as a safe and effective pain medication option.
New Drugs for Cancer, Rare Disease Can Now Cost More Than $20,000 a Month
The Wall Street Journal reported:
A new Amgen Inc. lung cancer treatment, Lumakras, carried a hefty price tag when it came out in 2021: $17,900 per patient monthly. Just over a year later, in December 2022, a second drug for the same type of cancer, Krazati from Mirati Therapeutics Inc., had an even higher price: $19,750 a month — a 10% premium.
As drugmakers face rising pressure to rein in repeat or annual price hikes on existing drugs, new brand-name medicines are coming to market with ever-higher price tags on day one. Previously, companies would carefully consider whether to crack big price barriers when launching a drug, like $5,000 and then $10,000 a month. Now, many new drugs for cancer and rare diseases routinely exceed those price thresholds, often coming in at more than $20,000 a month.
Two new cancer drugs approved in the U.S. in January — Eli Lilly & Co’s Jaypirca for mantle-cell lymphoma and Stemline Therapeutics Inc.’s Orserdu breast-cancer treatment — each cost at least $21,000 a month, or more than $250,000 for a full year of use.
Some new drugs that are intended to be one-time treatments now carry starting prices in the millions of dollars per patient. CSL Ltd’s Hemgenix, a gene therapy for the blood disorder hemophilia B, made its debut with a list price of $3.5 million after it was approved by U.S. regulators in November. CSL said the pricing reflects the treatment’s benefit to patients, potentially sparing them from repeat dosing of an older, costly drug.
As African Children Died, Doctors Fought to Get Toxic Indian Cough Syrup Banned
Last July, more than 20 children were admitted to the Paediatric Emergency Unit of the Edward Francis Small Teaching Hospital in Gambia with kidney failure. Many received dialysis, the usual treatment. Nearly all died. Doctors were mystified, four of them told Reuters: They usually see one or two such cases a year. Consultant pediatrician Vivian Muoneke, a 33-year veteran, was scared.
Three months later, the deaths of more than 70 Gambian children from Acute Kidney Injury were linked by global health officials to cough syrups made in India and contaminated with ethylene glycol (EG) and diethylene glycol (DEG). The patients were the first of about 300 children killed worldwide last year by contaminated cough syrups, not all of them made in India. It was the deadliest total poisoning on record from toxins that have been known to scientists for decades.
As authorities search for a culprit in this case, the story of how the Gambian doctors raised the alarm, then pushed for weeks for health officials to test for chemical poisoning and ban cough syrup sales, has not been previously reported.
Delays in testing the medicines cost weeks. When completed with help from the World Health Organization (WHO), the tests showed the medicines contained extremely dangerous levels of toxins and had been sold in bottles wrongly labeled as WHO-approved, Reuters found.
Rotavirus Vaccine Class Action Lawsuit Filed Against Merck Over Anticompetitive Scheme
Merck & Co. faces a class action lawsuit over its rotavirus vaccine, which claims the pharmaceutical company has engaged in an illegal and anticompetitive scheme to maintain its monopoly power over the pediatric vaccine market in the United States, causing purchasers of the rotavirus vaccines to pay unfair prices.
According to the lawsuit, Merck, which makes RotaTeq, has engaged in an anticompetitive vaccine bundling scheme that leverages the drug maker’s monopoly power in multiple vaccines administered to children, resulting in “supra-competitive” prices for the rotavirus vaccine, which does have a viable competing alternative sold by GlaxoSmithKline, under the trade name Rotarix.
The City of Baltimore claims that Merck has used this tactic on a variety of vaccines for children, allowing the company to charge whatever it wants. This includes the rotavirus vaccine, as well as the measles, mumps, and rubella vaccine (MMR), and the Gardasil human papillomavirus (HPV) vaccine.
One of the other products mentioned in the Merck vaccine lawsuit brought by the City of Baltimore is Gardasil, which has also resulted in a number of lawsuits against the drug maker for failing to warn about severe side effects that may result among children and young adults after receiving the HPV vaccine.
Bristol Myers, Pfizer, AbbVie Drugs Likely to Face U.S. Price Negotiation
The blood thinner Eliquis from Bristol Myers Squibb, Pfizer‘s breast cancer drug Ibrance and AbbVie‘s leukemia treatment Imbruvica are likely to be among 10 big-selling medicines subject to U.S. price negotiations for 2026, according to five Wall Street and academic analyses shared with Reuters.
Last year Congress passed the Inflation Reduction Act (IRA), giving the U.S. government power to start the first price negotiations over prescription drugs for its Medicare health program covering more than 60 million Americans, most over age 65.
The government will launch the negotiation process in September by naming the first drugs it plans to target. They are expected to be the 10 pharmacy-based prescription drugs it spends the most on for the year ending May 2023.
Chasing Pfizer, GSK’s 5-in-1 Meningococcal Vaccine Delivers Phase 3 Trial Win
Nearly three years after dosing the first patient in a phase 3 trial, GSK has now reported positive results from the trial of its much-anticipated combination meningitis vaccine. The shot, a combination of GSK’s approved vaccines Bexsero and Menveo, targets meningitis and blood poisoning caused by the A, B, C, W, and Y groups of meningococcal bacteria.
The serogroups A, B, C, W and Y cause nearly all invasive meningococcal disease (IMD) cases globally, GSK said in a statement. As it stands now in the U.S., protection from all five groups requires four injections from two separate vaccines. But GSK is looking to change that with its two-dose shot, which is administered six months apart.
The new data comes amid a race with Pfizer. The rivals started their phase 3 meningitis vaccine combination trials only two months apart in the summer of 2020, but Pfizer unveiled its positive data last year. The FDA is set to decide on Pfizer’s pentavalent candidate in October.
U.S. FDA Approves Pfizer’s Pain-Relief Nasal Spray for Migraine
The U.S. Food and Drug Administration on Friday approved Pfizer Inc.’s (PFE.N) nasal spray for migraine, giving patients access to a potentially fast-acting pain-relief option for headaches.
The drug Zavzpret, also known as zavegepant, was approved for the treatment of acute migraine with or without aura in adults, the company said. Aura refers to any neurological disturbance that appears shortly before or during the development of migraines.
Pfizer added Zavzpret and other migraine treatments, including Nurtec ODT, to it drugs portfolio through its $11.6 billion buyout of Biohaven Pharmaceutical last year.
Zavzpret belongs to a class of drugs called calcitonin gene-related peptide inhibitors and will compete with other therapies from AbbVie Inc, Eli Lilly and Co (LLY.N), Amgen Inc (AMGN.O) and Teva Pharmaceutical (TEVA.TA).
