Marketing: Page 4
-
Amylyx’s ALS drug again surpasses Wall Street expectations
Revenue from the biotech’s ALS therapy Relyvrio totaled $71.4 million in the first quarter, well above analyst estimates and helping the company turn a profit only months into the drug’s launch.
By Jacob Bell • May 11, 2023 -
Here’s what will change when the COVID public health emergency ends
Vaccines, which have been crucial to curbing the virus’ spread, will remain free for the vast majority of people in the U.S., but over-the-counter tests will no longer be covered for most.
By Shannon Muchmore • May 10, 2023 -
Trendline
Commercialization
New drugs for obesity and Alzheimer’s look set to become blockbusters, reshaping pharma marketing strategies just as many current top-sellers near looming patent cliffs.
By BioPharma Dive staff -
Abortion providers in 3 states sue over mifepristone restrictions
The lawsuit seeks to remove safety restrictions on mifepristone or, alternatively, prevent further altering of access to the drug.
By Sydney Halleman • May 9, 2023 -
Pfizer turns focus to new drugs as COVID vaccine revenue falls
The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.
By Jonathan Gardner • May 2, 2023 -
Lilly plans dash to market for weight loss drug after trial win
The drugmaker will use a priority review voucher in a bid to secure FDA approval of Mounjaro in obesity by late this year or early next.
By Jonathan Gardner • April 27, 2023 -
Roche’s new eye drug pressures Eylea with strong launch
One year after its market debut, the company’s AMD drug Vabysmo is on track for blockbuster sales as Regeneron’s rival treatment faces new threats.
By Jonathan Gardner • April 26, 2023 -
Lilly sells emergency diabetes drug for $500M
The divestment of Baqsimi to Amphastar could net Lilly more than $1 billion if sales goals are met.
By Jonathan Gardner • April 24, 2023 -
Supreme Court maintains access to abortion pill, blocking restrictions on its use
The stay suspends a Texas judge’s order that invalidated the FDA’s approval of mifepristone, keeping it available while a circuit court hears the case.
By Delilah Alvarado • Updated April 22, 2023 -
Supreme Court delays decision in battle over abortion pill
An administrative stay of a Texas district court ruling will remain in place through Friday, pushing out a Supreme Court decision in the closely watched case over the drug mifepristone.
By Delilah Alvarado • April 19, 2023 -
FDA again knocks back Alvotech’s Humira biosimilar
The agency rejected the partners’ copycat version of AbbVie’s blockbuster drug for a second time, citing problems spotted during the inspection of a manufacturing facility.
By Jonathan Gardner • April 14, 2023 -
Novo boosts sales outlook on strong demand for obesity drug
The Danish drugmaker nearly doubled the 2023 forecasts for Wegovy and Ozempic in the latest indicator of the sales potential of an emerging and competitive class of weight loss drugs.
By Kristin Jensen • April 13, 2023 -
Federal judge invalidates FDA approval of abortion pill
The April 8 decision by a district court judge in Texas set off a high-profile chain of litigation that has now reached the Supreme Court, whose decision could carry ripple effects for drug regulation more broadly.
By Delilah Alvarado • April 8, 2023 -
FDA withdraws preterm birth drug’s approval, denying maker’s request for delay
Commissioner Robert Califf and Chief Scientist Namandjé Bumpus determined there was “no justification” for keeping Covis Pharma’s controversial treatment Makena on the market.
By Ned Pagliarulo • April 6, 2023 -
FTC wades into dispute between Supernus, generic competitor
The agency, which is taking a closer look at the pharma industry, submitted a brief to federal court in a case it says could have “significant implications” for Parkinson’s patients.
By Kristin Jensen • March 22, 2023 -
Pear, tight on cash, considers strategic alternatives
The digital therapeutics firm is considering a sale, merger or other deal following struggles to market its app-based treatments.
By Elise Reuter • March 17, 2023 -
VA to cover Leqembi for veterans with early Alzheimer’s
The agency’s decision on Eisai and Biogen’s new drug contrasts with a stringent Medicare policy that limits coverage to patients in clinical trials.
By Christopher Newman • March 14, 2023 -
Amylyx’s ALS drug sales impress Wall Street
In its first full quarter on the market, Amylyx’s Relyvrio generated nearly $22 million in revenue, or about five times what some analysts forecast last month.
By Jacob Bell • March 13, 2023 -
FDA clears first at-home flu and COVID test, days after its developer files for bankruptcy
The test’s maker, Lucira, said the agency’s “protracted” authorization process caused it to miss out on test sales in the latest flu season.
By Nick Paul Taylor • Feb. 27, 2023 -
Medicare maintains limits on Eisai’s new Alzheimer’s drug
Eisai and Biogen have data showing Leqembi slows cognitive decline, but CMS won’t budge until FDA converts its approval from accelerated to full.
By Jonathan Gardner • Feb. 23, 2023 -
Doctors largely comfortable with biosimilar drugs, but question economics: report
Weeks after the first Humira copycat launched in the U.S., a survey by Cardinal Health suggests insurer mandates will drive biosimilar adoption.
By Jonathan Gardner • Feb. 22, 2023 -
GSK wins full approval for cancer immunotherapy, looks to expand use
The drugmaker converted Jemperli’s accelerated approval in endometrial cancer, while outside advisers endorsed its plan to study the Keytruda rival in rectal tumors.
By Jonathan Gardner • Feb. 10, 2023 -
Cigna restricts coverage of new ALS drug, deepening fears about access
The health insurer’s national formulary considers Amylyx Pharmaceuticals’ Relyvrio to be "experimental, investigational or unproven for any use,” and now does not recommend covering it.
By Jacob Bell • Feb. 7, 2023 -
Eisai gives first glimpse into Alzheimer’s drug launch
In the month since its U.S. approval, Leqembi has had its first sale, its first prescription written and its first administration to a patient.
By Jacob Bell • Feb. 6, 2023 -
Roche writes off $3B on lower sales forecasts for gene therapies, cancer drugs
Among the drugs Roche recorded impairment charges on are four gene therapies acquired in the company's 2019 deal for Spark Therapeutics.
By Jonathan Gardner • Feb. 3, 2023 -
Lilly reports fast sales for new diabetes drug
Still, fourth quarter sales for Mounjaro were slightly below high Wall Street forecasts and didn’t offset falling revenue from Lilly’s COVID-19 antibodies.
By Jonathan Gardner • Updated Feb. 2, 2023