AbbVie and Novartis’ Sandoz unit reached a global resolution of all intellectual property-related litigation over Sandoz’s proposed biosimilar Hyrimoz for the reference drug Humira (adalimumab). Under the terms of the settlement, AbbVie has granted Sandoz a non-exclusive license to intellectual property relating to Humira beginning on egin on October 16, 2018 in most countries in the European Union and September 30, 2023 in…
Johnson & Johnson Pays $175 M for Rights to Arrowhead’s Experimental RNAi Therapeutic for Hepatitis B
Janssen Pharmaceuticals, a unit of Johnson & Johnson, entered a deal with Arrowhead Pharmaceuticals potentially worth more than $3.7 billion to develop the latter’s ARO-HBV for patients with chronic hepatitis B virus (HBV) infection, as well as additional RNAi therapeutics. Johnson & Johnson made an upfront payment to Arrowhead of $175 million, with the company…
Pulling Down the Wall Between R&D and Manufacturing
Q: What type of products can be tested using simulation platforms? Lybrook: There’s no limit. Usually, R&D develops the product and then they throw it over the wall to manufacturing, and then manufacturing must figure out the best way to produce the product on their own, looking at automation first and so on. We don’t…
FDA Approves New Drug for the Preventive Treatment of Migraine
The FDA approved Eli Lilly’s Emgality (galcanezumab-gnlm) for the preventative treatment of migraine in adults. This is the third FDA-approved biologic that acts by reducing the effect of CGRP, a molecule believed to play a role in migraine. Aimovig (erenumab-aooe) was approved on May 17, 2018 and Ajovy (fremanezumab-vfrm) was approved on September 14, 2018. “Despite…
Aetna Sells Medicare Drug Business to Pave Way for CVS Takeover
Heath insurer Aetna plans to sell its Medicare prescription drug business to WellCare Health Plans, a move that will potentially clear the way for CVS Health to complete its $69 billion takeover of the insurer. While Aetna has not disclosed the terms of the sale to WellCare, the company did state that its Medicare Part…
Bayer, Novartis Lose Case Seeking to End NHS Use of Roche’s Avastin
Novartis and Bayer’s case against National Health Services in Northern England has been dismissed by the U.K. High Court. The court ruled that NHS can continue to use Roche’s Avastin (bevacizumab) for the treatment of wet age-related macular degeneration (AMD) despite Novartis and Bayer’s claim that Avastin should not be used by NHS because it…
Clovis Oncology, Execs Fined Millions for Misleading Investors About Lung Cancer Drug
On Tuesday, The U.S. Securities and Exchange Commission (SEC) announced that Clovis Oncology, CEO Patrick Mahaffy, and former Chief Financial Officer Erle Mast have been instructed to pay more than $20 million in penalties to settle accusations of misleading investors about the company’s developmental lung cancer drug rociletinib. Stephanie Avakian, co-director of the SEC’s enforcement…
Top 25 Global Pharmaceutical Companies by Market Cap 2018
GlobalData released the results of their pharmaceutical market analysis, highlighting the top 25 publically traded global pharmaceutical companies by Market Cap (Mcap). The collective Mcap of the top pharma companies reached roughly $2.7 trillion, with growth at 1.1 percent in Q2 2018. The leading companies—Merck US, Bayer, GSK, Eli Lilly, CSL, and Shire—achieved double digit…
Pfizer to Suspend North Carolina Plant Operations as Hurricane Florence Approaches
As Hurricane Florence barrels towards the Carolina coast, Pfizer will take precautionary measures, temporarily shutting down operations at its Hospira sterile injectables manufacturing facility in Rocky Mount, North Carolina. In response to predictions that Florence will hit land sometime Thursday evening or Friday morning, Pfizer has scheduled to shutdown the plant early Thursday. As of late afternoon on…
Akcea to Cut Jobs Following FDA Rejection
In the wake of the FDA’s rejection of Waylivra for the treatment of familial chylomicronaemia syndrome (FCS), Akcea Therapeutics disclosed that it plans to cut 10 percent of its workforce. The company received a complete response letter from the FDA last week, and the accompanying press release offered only that the letter was in regards to Akcea’s…