Arena Pharmaceuticals got the OK to enter the prescription weight loss drug competition. The company has been waiting for the Drug Enforcement Agency to determine where Belviq should live on its schedule of controlled substances before it could begin marketing the drug. The DEA notice goes up in Wednesday’s Federal Register, and Arena can implement its marketing strategy 30 days after publication. The Schedule IV designation — the agency’s second-least-restrictive — also showers the company with a $65 million milestone payment from Eisai, which will market the prescription medication. The company’s European strategy is on hold – Arena pulled its review application last week when the regulator requested additional information. The EU has rejected the offering of competitor Vivus twice. The DEA chose to review the drug because its active intergradient lorcaserin can produce a “high” or hallucinogen effect at high doses (doses higher than necessary to lose weight with the drug). Belviq is the first approved drug indicated for weight loss in 13 years.
Takeda is buying infectious disease company Inviragen for an initial payment of $35 million, with up to $215 million in additional payments which are linked to clinical development and marketing milestones. Colorado-based Inviragen merged with the Singapore-based vaccine company SingVax four years ago, and the post-merger collaboration includes a pipeline count of four experimental therapies for conditions including Hand, Foot and Mouth Disease and a Phase II treatment called DENVax for dengue fever.
District Judge Edward Korman is going to decide this week if the FDA had the authority to put an age restriction on access to Plan B, the contraceptive also known as the morning after pill, reported Reuters. The Food and Drug Administration announced last month that it was increasing access to the pill, but within limits. Reuters quotes Korman as saying the age requirement is “a lot of nonsense” because teens may not have the requisite photo identification. The drug has been available to women 18 and older without a prescription since 2006 – and could be prescribed to girls below that age. Korman has argued that maintaining two-tiers of access “is an excuse to deprive the overwhelming majority of women their right to obtain contraceptives without unjustified and burdensome restrictions,” the Wall Street Journal noted last month.
Cubist Pharmaceuticals’ experimental antibiotic, CXA-201, has been granted breakthrough therapy designation for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia as well as complicated urinary tract infections. CXA-201 was also granted breakthrough therapy designation for complicated intra-abdominal infections in February.
