Articles by Anna Rose Welch

  1. FDA News Roundup: Actavis, Debiopharm, Merck, Astellas, And More 9/11/2014

    The FDA has been busy the past week granting fast-track status to drugs from Acadia, Ipsen, VentiRx, Merck, and Aradigm. The agency has also approved, reviewed, and granted orphan drug/QIDP designations to Debiopharm, Prana, and more.

  2. EMA, NICE, EC News Roundup: Allergan, Alexion, Innate Pharma, And More 9/10/2014

    Vifor Pharma was granted marketing authorization in Europe for Velphoro (sucroferric oxyhydroxide), which is intended for the treatment of Chronic Kidney Disease (CKD) patients that are on hemodialysis or peritoneal dialysis. The drug is a non-calcium, iron-based chewable phosphate binder that demonstrated in a phase 3 trial it could sufficiently control hyperphosphatemia in fewer pills than the current standard of care, sevelamer carbonate. The FDA approved Velphoro for the treatment of patients with CKD that are undergoing dialysis in November 2013, and the drug entered the market in March.

  3. FDA News Roundup: Merck, UCB, Pfizer, Ipsen, And More 9/8/2014

    In the news this week, the FDA recently approved the first immunotherapy for melanoma, as well as drugs for epilepsy and myelodysplastic syndrome. The FDA also cleared several drugs for new indications, QIDP status, and orphan drug status.

  4. What You Missed From The FDA Last Week—August 25-29, 2014 9/2/2014

    SK’s and Pfizer’s joint venture ViiV Healthcare was awarded an FDA approval for its combination HIV drug, Triumeq. The treatment is a combination of three different drugs: GSK’s Tivicay, abacavir, and lamivudine. Triumeq is the second single-dose HIV treatment with an integrase inhibitor to hit the market since Gilead Sciences’ $539 million player, Stribild. Tivicay, one of the key components of the Triumeq, is expected to his $1 billion in sales by 2016, reaching a high of $2.2 billion in 2018, Bloomberg analysts say. Tivicay sales are also expected to bolster Triumeq as well, since the drug is based off of Tivicay.

  5. What You Missed From Regulatory Agencies Recently – August 18-28, 2014 8/28/2014

    The past two weeks saw approvals and orphan drug designations for Biogen Idec, Bristol-Myers Squibb, Basilea Pharma, Cubist, and Celegene, among others.

  6. What You Missed From The FDA Last Week—August 18-22, 2014 8/25/2014

    The FDA approved Biogen Idec’s injectable drug, Plegridy, for relapsing-remitting multiple sclerosis. It will be entering Biogen Idec’s MS portfolio with the company’s first MS drug, Avonex, which will still remain in the market. However, Plegridy contains the polyethylene glycol, or peg, polymer which cuts down on the frequency of doses patients need to take. The drug is injected into muscle every two weeks, compared to Avonex which needs to be taken once every week. Plegridy was recently approved by the European Commission to be sold in 28 countries.

  7. What You Missed From The FDA Last Week—August 11-15, 2014 8/18/2014

    Takeda’s Millennium announced that Velcade was approved for the retreatment of adults with multiple myeloma (MM) who had previously seen positive results from treatment with Velcade and that had relapsed within 6 months following that prior treatment. The labeling update covers dosing guidelines and includes the safety and efficacy findings for Velcade as both a single agent and in combination with dexamethasone in patients previously treated with Velcade.  The sNDA was supported by results from the international phase 2 RETRIEVE study that demonstrated the drug achieved a 38.5 percent overall response rate in MM patients previously treated by Velcade.

  8. What You Missed From The FDA Last Week—August 5-9, 2014 8/11/2014

    The FDA expanded the approval of the drug Lumizyme for patients with infantile-onset Pompe disease to include patients under 8 years old. The rare genetic disorder causes heart and skeletal muscle weakness that leads to respiratory weakness and death for 1 in every 40-300,000 births.

  9. What You Missed From Regulatory Agencies Last Week—July 28-August 1, 2014 8/7/2014

    In the news this week, the EMA and other regulatory bodies made decisions regarding drugs from Novo Nordisk, Novartis, Takeda, Merck, and other pharma companies.