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Novartis aims to solve EpiPen shortage with generic launch of Symjepi to US pharmacies

Novartis has announced the immediate availability of its generic epinephrine auto-injector in pharmacies throughout the US, as it moves to remedy the nation’s shortage of the potentially life-saving drug.

The shortage, which has now gone on for an entire year, hinges on the availability of Mylan’s EpiPen, the most common and well-known version of the drug, in what the FDA has characterised as “manufacturing delays”. The problem, according to Mylan, lies at the feet of Meridian Medical Technologies, a Pfizer subsidiary that manufactures the devices.

Teva's EpiPen generic retails for same price as Mylan's own

Israeli generics firm Teva has revealed the price tag of its generic version of Mylan’s EpiPen epinephrine auto-injector, and, at $300 wholesale for a pack of two, it comes in at exactly the same point as Mylan’s own long-anticipated generic version.

The announcement means that patients have two alternative options for the therapy, which both come in at less than half the cost of the branded product.

MHRA to extend EpiPen expiry dates to tackle shortages

The British government has extended the expiry date on epinephrine pens amid a shortage in the UK.

The Danish pharmaceutical company ALK announced that it was working with the Medicines and Healthcare products Regulatory Agency (MHRA) as the agency decides which specific batches of the Jext epipens will receive an extension on their expiry.

ALK estimates that approximately 100,000 Jext pens in circulation in Britain will expire soon.

FDA approves first-ever generic EpiPen versions, courtesy of Teva

The FDA has announced the approval of the first generic versions of Mylan’s EpiPen and EpiPen Jr epinephrine auto-injectors as a treatment for anaphylactic shock, the first available since the originator product was approved over two decades ago.

The new generic versions, manufactured by Teva, have secured approval after several years of attempts by Mylan to block their progress.

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It's the end of another week and there's really been one story that has dominated the headlines – Takeda’s potential takeover of Shire. It should come as no surprise that our most viewed story of the week relates to the purchase.

EpiPen shortage hits UK and Canada hard, but not US

Manufacturing issues at the single Pfizer plant that produces the EpiPen epinephrine injector has caused serious shortages in the UK and Canada, but the US remains unhurt by supply issues.

The situation has developed to the point where Canada is now in direct conversation with the FDA to determine whether it will be able to gain access to some of US’ supply of the medicine.

Potential issues with supply of the EpiPen were announced back in January but it had been suggested the problems would be resolved by March.

Mylan looks to muscle in on Allergan’s Botox territory

Mylan announced, alongside its financials, that it had signed a global collaboration and licensing agreement with Revance Therapeutics to partner on a Botox biosimilar.

Allergan’s Botox is its major growth driver and biosimilar competition could hit the company hard – it announced fourth quarter revenues of $228.4 million in the cosmetic sector and $367.2 million in the therapeutic sector.

FDA unveils guidelines to help generic medical device versions reach the market

The scandal surrounding Mylan’s price-hiking of its flagship EpiPen epinephrine auto-injector was the news of last summer, continuing to grab headlines as the months went on. The debate around generic competition to provide patients with a more affordable alternative has continued to rage on, and now the FDA is looking to crack down on loopholes preventing such products from reaching the market.

Investors demand resignation of Mylan executives over pay packages

As confidence in Mylan continues to fall and share prices plummet after last year’s EpiPen pricing scandal and subsequent PR faux pas, an investor group is calling for the resignation of the company’s Chairman and Director over its executive pay packages and price hiking practices.

New rival to EpiPen receives FDA approval to shake up market

Adamis Pharmaceuticals has revealed that it received FDA approval for its EpiPen rival to enter the market. Its product, to be sold under the brand name Symjepi, is smaller than the EpiPen and the manufacturer claims it is easier to use.

The price of the product is not yet known, as the company still has to find a marketing partner before it aims to reach the market in the second half of the year. However, Adamis suggests that it will be marketed as a lower cost alternative to Mylan’s EpiPen.

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