PHARMACY

FDA commissioner Gottlieb touts record number of generic drug approvals in July

BY Sandra Levy

The Food and Drug administration beat its record for drug approvals in July, FDA commissioner Scott Gottlieb tweeted yesterday. “July saw the highest number of approval actions in the history of the generic drug program in a single month with 126 total approvals (96 full) approvals plus 30 tentative approvals,” Gottlieb said.

The Activities Report of the Generics Drug Program shows that June 2018 was also a month in which generic drug approvals soared, with 74 approvals, and 18 tentative approvals. In October 2017, the FDA approved 87 generic drugs. In November 2017 the FDA gave the nod to 87 generic drugs.

In December 2017 there were 78 generic drug approvals. January 2018 saw only 25 generic approvals. February 2018 had the FDA giving the nod to 32 generics and in March, generic drug approvals tallied 57.

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PHARMACY

Aralez to sell assets valued at $250M amid Chapter 11 filing

BY Sandra Levy

Specialty pharmaceutical firm Aralez Pharmaceuticals announced today that it intends to enter into purchase agreements with two separate stalking-horse purchasers to sell its main operating businesses: an agreement to sell its Vimovo royalties and Canadian operations to Nuvo Pharmaceuticals in a transaction valued at $110 million and an agreement to sell its Toprol-XL franchise to its secured lender, certain funds managed by Deerfield Management Company in a transaction valued at $140 million.

Aralez is also engaged in ongoing efforts to sell the assets not being sold in either of the proposed transactions and intends to wind down its operations following the consummation of the sales, according to the company.

Aralez, and its Canadian subsidiary, Aralez Pharmaceuticals Canada has elected to commence voluntary proceedings under Canada’s Companies’ Creditor Arrangement Act (the “CCAA”) in the Ontario Superior Court of Justice. Aralez’s subsidiaries incorporated in the United States and Ireland have elected to file voluntary petitions under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of New York (together with the CCAA proceedings, the “Restructuring Proceedings”).

“Following a thorough financial and strategic review, we believe that these sales, together with an auction process under court supervision are in the best interests of the Company and its stakeholders,” Aralez CEO Adrian Adams, said in a press release statement.

Aralez, together with its subsidiaries, intends to seek and obtain customary relief from the courts to permit it to continue to operate its business in the ordinary course without interruption during the sale process.

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Rite Aid rolls out seasonal flu shots

BY David Salazar

Ahead of flu season, Rite Aid on Friday announced the availability of seasonal flu shots at more than 2,500 of its pharmacies. The company said that on the heels of a vicious flu season, earlier is better for immunization.

“Last year’s flu season was one of the most severe seasons in recent years, with high flu activity across the country and a record number of flu-related hospitalizations,” said Jocelyn Konrad, Rite Aid executive vice president of pharmacy. “Since we can’t predict what this flu season will be like, we urge everyone to get a flu shot at Rite Aid today, because getting vaccinated is the easiest and most effective way to fight the flu.”

Rite Aid is offering a quadrivalent flu vaccine, which protects against four strains of flu — A H3N2, A H1N1 and two strains of influenza B virus. It also offers a trivalent vaccine and Fluad, a trivalent vaccine with adjuvant, which helps boost the immune response to vaccination and is approved for patients 65 years old and older.

Rite Aid said the Centers for Disease Control and Prevention recommend everyone six months old and older get a flu vaccination. In particular, older patients, people with diabetes, pregnant women and patients with asthma and other chronic lung disease, as well as patients with kidney and liver disorders, heart disease and those with compromised immune systems.

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