Following initial approvals for rheumatic diseases, Bristol Myers Squibb Co.'s Orencia (abatacept) has become the first FDA-approved drug for the prevention of acute graft-vs.-host disease (aGVHD), in combination with calcineurin inhibitors and methotrexate, both types of immunosuppressants.
Little more than a year since FDA approval of its COVID-19 vaccine, Pfizer Inc. has published final phase II/III data on its oral antiviral candidate, Paxlovid (nirmatrelvir + ritonavir), confirming that, for non-hospitalized, high-risk adults with COVID-19, taking the drug within three days of symptom onset reduced all-cause risk of hospitalization or death by 89% vs. placebo.
Mitsubishi Tanabe Pharma Corp.'s Medicago Inc. plans to "imminently" seek Health Canada approval for its plant-based COVID-19 vaccine candidate, MT-2766, after top-line phase III results showed an overall vaccine efficacy rate of 71% against all variants of SARS-CoV-2.
Milan-based Recordati SpA has proposed acquiring the global specialty pharma Eusa Pharma Ltd., a specialist in rare and niche oncology, for about €724 million (US$817.5 million) net of around €26 million in debt Eusa held at last report, midyear. The transaction offers Recordati a "great growth opportunity" while giving it the chance to "build scale in a new-for-us and very attractive and underserved therapeutic area," thus providing further diversification for Recordati's existing rare diseases business, said Chairman Andrea Recordati.
Swedish Orphan Biovitrum AB shares (STO:SOBI) fell 25% Dec. 3 as investors behind Agnafit Bidco AB, previously poised to pay about SEK72.17 billion (US$7.97 billion) for the company, withdrew their bid as shares tendered fell just short of the 90% needed to complete the deal. The bid was seen as likely to succeed after Investor AB, which owns 35% of the capital and votes in the company, commonly called Sobi, supported it. However, with only 87.3% of outstanding shares tendered as of Dec. 3, Agnafit decided to drop the offer, foregoing further extension of the acceptance period, which was earlier extended by ten days to Nov. 26 in hopes of collecting enough support.
Novartis AG, keen to expand its central nervous system franchise as generics chase down crown jewel Gilenya (fingolimod), has secured rights from UCB SA to co-develop and commercialize two potential Parkinson's disease therapies for $150 million up front and milestone payments approaching $1.5 billion.
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity.
Shares of Krystal Biotech Inc. (NASDAQ:KRYS) rocketed 121.7% higher, to $88.44 on Nov. 29, after top-line data showed its investigational gene therapy for dystrophic epidermolysis bullosa (DEB) achieved the primary endpoint of a pivotal phase III trial, healing 67% of skin wounds associated with the disease vs. placebo at six months.
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity.
A phase IIb trial of Connect Biopharma Holdings Ltd.'s CBP-201 in adults with moderate-to-severe atopic dermatitis (AD) showed all three doses tested reduced eczema severity vs. placebo by a statistically significant percentage at 16 weeks, meeting the trial's primary efficacy endpoint.
