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FDA expands indication for Eylea to cover all stages of diabetic retinopathy

The FDA has expanded the indication for Regeneron’s Eylea (aflibercept) to include all stages of diabetic retinopathy.

Regeneron chief scientific officer George Yancopoulos commented: “with today's FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases.”

FDA approves record breaking 971 generic drugs in 2018

The FDA approved a record 971 generic drugs in the 2018 fiscal year, giving the go-ahead to 110 generics in October alone, it has emerged.

The year saw an improvement on the previous record of 937 generics approvals set in 2017. The cost saving medicines were said to have saved consumers as much as $26 billion between January 2017 and July 2018.

FDA advisory panel approves AcelRx's opioid pain drug Dsuvia

An FDA advisory panel voted 10 to 3 to recommend the approval of AcelRx Pharmaceuticals’ opioid pain drug Dsuvia (sufentanil) to manage moderate-to-severe acute pain in adults in medically supervised settings.

The go-ahead has come after the federal agency questioned the drugs superiority and raised concerns surrounding the medication’s small pill size which could lead to accidental use.

US FDA approves HPV vaccine for men and women aged 27-45

The US Food and Drug Administration have approved the use of HPV vaccine Gardasil 9 for both men and woman between the ages of 27 and 45. Previously the vaccine had only been approved for those between the ages of 9 and 26.

Teva shares soar after migraine treatment Ajovy approval

Shares in the Israeli pharma firm Teva soared on Sunday after the announcement that the US Food and Drug Administration (FDA) had approved the company’s migraine treatment Ajovy.

Having faced financial difficulties in recent years the approval may mark a turn in fortunes for the indebted Israeli drugmaker.

Protesters in Manchester call on NICE to approve Biogen's $750,000 drug Spinraza

Image Credit: Juliux | Manchester Town Hall

Protesters in Manchester have called on the National Institute of Health and Care Excellence (NICE), to overturn their rejection of the Spinal Muscular Atrophy (SMA) treatment Spinraza, after the public body chose not to approve the orphan drug for use on the NHS due “to uncertainties over its long-term effectiveness and its extremely high cost.”

FDA approves Bristol Myers Squibb's Opdivo in small-cell lung cancer

Image Credit: Bristol-Myers Squibb
Image Credit: Bristol-Myers Squibb

The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) for patients with metastatic small-cell lung cancer (SCLC), as the first and only Immuno-Oncology treatment option for whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy.

The approval was granted on an accelerated approval basis however continued approval may be based on verification and description of clinical benefit in confirmatory trials.

Chinese regulators approve Roche's Alecensa in regulatory shift

China’s National Drug Administration has granted rapid approval for Roche’s lung cancer treatment Alecensa (alectinib).

Chinese regulators have in the past approved drugs years later than other regions such as Europe and the United States. However the lengthy regulatory process and the associated lack of access to drugs has turned patients towards the grey market.

Rare lung cancer drug approved in Scotland

Image Credit: Yale Rosen

The Scottish Medicines Consortium has approved Roche’s cancer drug alectinib for the treatment of patients with untreated advanced non-small-cell lung cancer (NSCLC) whose tumours are identified as ALK-positive.

The drug has been shown to improve outcomes in comparison to current standards of care. The treatment proved to reduce the risk of disease progression and death by 53% and was shown to reduce the risk of tumours in the central nervous system (CNS) by 84%.

EU Commission grants market authorisation for Sandoz’ Humira biosimilar

Medicines in an automated pharmacy

The European Commission has granted marketing authorisation to Sandoz’ biosimilar Hyrimoz for use in all indications, including rheumatoid arthritis, plaque psoriasis, Crohn's disease, uveitis and ulcerative colitis.

The Novartis subsidiary Sandoz, gained approval for its anti-inflammatory biosimilar Hyrimoz, which will be available as a 40mg pre filled syringe for treatment of a range of conditions. The drug however, will not be available in the UK before 16 October 2018.

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