FDA has granted accelerated approval to Leqembi (lecanemab), the amyloid beta-protein inhibitor from Eisai (OTCMKTS:ESALY) and Biogen (Nasdaq:BIIB) at an annual launch price of $26,500. The Institute for Clinical and Economic Review (ICER) had decided that the monoclonal antibody lecanemab should be priced less than $20,600 to be cost-effective. Eisai, which is solely responsible for…
Endevica Bio’s COO on finding balance and freedom in pharma
LeAnn Kuhlmann-Qi is the chief commercial officer of Columbia, Missouri–based Endevica Bio. The company’s lead drug candidate is TCMCB07, a peptide melanocortin-4 antagonist for cachexia stemming from cancer and other chronic conditions. Holding an MBA. from the University of Missouri, Kuhlmann-Qi has extensive experience managing the business aspects of early-stage biotechnology companies. She is also…
Drug Discovery & Development’s top stories of 2022
After the majority of pharmaceutical companies released their earnings reports for 2022, we released our annual Pharma 50 feature detailing how the pharma landscape has evolved. Four of the five most popular pieces of content on Drug Discovery & Development were part of the Pharma 50 feature. In the past year, Pfizer (NYSE:PFE) cemented its…
Small molecule trends to follow in 2023
As the world begins to emerge from the pandemic, there are signs of an investment slowdown after record venture capital (VC) funding levels driven by COVID-19 treatment and prevention. “Even with this slowdown, we see that VC investment remains very high,” said Christian Dowdeswell, vice president, head of commercial development, small molecules at Lonza in…
Novavax launches Phase 2 study for COVID-19-flu shot
Vaccine developer Novavax (Nasdaq:NVAX) has begun a Phase 2 study of its COVID-19-influenza combination (CIC) shot as well as an influenza-only vaccine candidate. Rivals Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE)/BioNTech (Nasdaq:BNTX) have made similar moves. Moderna has a slew of flu vaccine candidates in its pipeline, including MRNA-1010, which is the subject of a Phase 3…
Psychedelic therapy at a crossroads at the dawn of 2023
In several ways, psychedelic therapy continued to make strides toward legitimization in 2022. Michael Pollan’s best-selling psychedelic treatise “How to Change Your Mind” formed the basis for a popular Netflix series. Several celebrities declared that psychedelics had improved their lives. Decriminalization efforts gaining steam Colorado decriminalized psychedelic plants, as did the city of San Francisco.…
How the antidepressant landscape evolved in 2022
One in five people will experience major depressive disorder (MDD) at some point in their lives. Although depression is common, traditional selective serotonin reuptake inhibitors (SSRIs) such as Prozac (fluoxetine) and serotonin-norepinephrine reuptake inhibitors (SNRIs) help about 40–60% of people within six to eight weeks. For those who don’t respond to the first treatment, however,…
Guselkumab analysis shows psoriatic arthritis patients with early efficacy had sustained benefit
At the American College of Rheumatology (ACR) meeting, Janssen Immunology presented a Tremfya (guselkumab) posthoc analysis demonstrating stringent disease activity control at two years in patients with psoriatic arthritis. In addition, the analysis of Phase 3 DISCOVER-2 data indicated that patients with active psoriatic arthritis with a response at week eight to the IL-23 inhibitor…
Congress passes FDA act that would do away with animal testing requirement
The U.S. House has approved the FDA Modernization Act 2.0, which would end the animal testing requirement for new drugs and biosimilars. The bill doesn’t completely ban testing on animals but enables drug developers to use alternatives when feasible. In September, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002. The new policy, known as the…
Hydroxychloroquine tied to lower Alzheimer’s risk in arthritis patients in study
A recent analysis involving more than 100,000 patients with rheumatoid arthritis concluded that those receiving hydroxychloroquine (HCQ) had a lower risk of developing Alzheimer’s disease than those taking the immunosuppressant methotrexate. Nature‘s Molecular Psychiatry published the analysis. HCQ is a disease-modifying anti-rheumatic drug (DMARD) that can reduce pain and swelling associated with arthritis. It is also…
Can BioNTech’s BNT165b1 malaria vaccine stand up to Oxford’s R21?
The mRNA vaccine company BioNTech (Nasdaq:BNTX) has begun a Phase 1 study of BNT165b1, a multi-antigen malaria vaccine candidate that belongs to its BNT165 malaria program. Researchers at Oxford University are farther along with their R21/Matrix-M vaccine. A recently completed Phase 3 trial focused on R21. It could win licensure in 2023. In a Phase…
FDA approves bispecific antibody from Genentech
The FDA has approved Genentech‘s Lunsumio (mosunetuzumab-axgb), a novel bispecific antibody for relapsed or refractory follicular lymphoma (R/R FL). The indication covers R/R FL patients who have received at least two prior systemic therapies. Patients with the cancer subtype have had limited treatment options and significant morbidity and mortality. The approval of Lunsumio is the…
Atai Life Sciences’ stock dips after announcing Phase 1 data
Atai Life Sciences (Nasdaq:ATAI) announced inconclusive data regarding the effects of the kratom-derived compound KUR-101 on respiration in a Phase 1 study. The company’s stock was down about 9% in mid-day trading, trading at $2.77. The drug candidate yielded dose-dependent analgesic effects in Part 1 of the study, which assessed the safety and efficacy of various dose…
FDA approves Roche’s tocilizumab to treat COVID-19 in hospitalized adults
Roche (SIX:RO,ROG; OTCQX:RHHBY) announced that it received FDA approval for the intravenous (IV) monoclonal antibody Actemra (tocilizumab) for hospitalized patients with severe COVID-19. The indication covers hospitalized adults receiving systemic corticosteroids who need supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Tocilizumab targets the interleukin-6 receptor. It first won FDA approval…
Vistagen acquires Pherin Pharmaceuticals for its neuroactive steroid pipeline
The biopharma Vistagen (Nasdaq:VTGN) has agreed to acquire privately-held Pherin Pharmaceuticals for roughly 12.4 million shares of Vistagen stock. It will sweeten the deal with “a nominal amount of cash,” the company said in a press release. The deal is subject to customary closing conditions. In October 2018, South San Francisco, California–based Vistagen announced that…
At ASH, Genentech showcases expanded hematology portfolio that includes bispecific antibodies
At ASH 2022, Roche (SWX: ROG) subsidiary Genentech presented new data demonstrating the potential of glofitamab and mosunetuzumab, its investigational CD20xCD3 T-cell engaging bispecific antibodies, as fixed-duration, off-the-shelf treatment options for two types of non-Hodgkin’s lymphoma (NHL) – large B-cell lymphoma (LBCL) and follicular lymphoma (FL), respectively. “The new data demonstrated durable and impressive patient…
Otonomy plans to dissolve
The neurotology biopharma Otonomy (Nasdaq:OTIC) is planning to liquidate and dissolve its business. It plans to distributing any remaining cash to shareholders after its operations have been suspended and its pipeline assets have been sold. The company also announced that it had terminated all of its employees effective December 15. In 2017, Otonomy announced that …
Gilead and Arcus share positive data from Phase 2 ARC-7 study of zimberelimab
Gilead Sciences (Nasdaq: GILD) and Arcus Biosciences (NYSE:RCUS) are touting positive results from the fourth interim analysis of the randomized, open-label Phase 2 ARC-7 study in patients with first-line metastatic non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO). Patients in the arms who received the investigational Fc-silent anti-TIGIT monoclonal antibody…
Rilzabrutinib study highlights cognitive impairment in patients with chronic immune thrombocytopenia
A Phase 1/2 study (NCT03395210) investigating Sanofi (Nasdaq:SNY) Bruton tyrosine kinase inhibitor rilzabrutinib in immune thrombocytopenia (ITP) has also shed light on the cognitive impairment involved in the disease. Patients with ITP, an autoimmune disease that involves increased platelet destruction, have often complained of fatigue, problems with cognition and other symptoms that physicians have dismissed,…
FDA approves cariprazine as an adjunctive treatment for major depressive disorder
AbbVie (NYSE:ABBV) has announced that the FDA has approved Vryalar (cariprazine) as an adjunctive therapy to antidepressants to treat major depressive disorder (MDD) in adults. Cariprazine is a novel atypical antipsychotic drug (APD) that works as a partial agonist at the dopamine D2 and D3 receptors and serotonin 5-HT1A receptors. It works as an antagonist…
Iptacopan from Novartis could become preferred therapy for paroxysmal nocturnal hemoglobinuria
Novartis (NYSE: NVS) recently announced that the pivotal iptacopan Phase 3 APPLY-PNH trial met both its primary and most secondary endpoints in patients with paroxysmal nocturnal hemoglobinuria (PNH). The company recently presented the data at this year’s American Society of Hematology (ASH) meeting. Almost all iptacopan recipients had blood-transfusion independence and had clinically meaningful patient-reported-fatigue improvements. There…
The top 10 pharma M&A deals of 2022
2022 was a shaky year for M&A deals in the pharmaceutical and life sciences sector, as PwC recently surmised. That’s not surprising, given the recession fears and inflation themes common throughout the year. That said, Amgen (Nasdaq:AMGN) and Pfizer bucked the trend by spending 11-figure sums on M&A deals. Bristol Myers Squibb, Biocon Biologics and GSK…
Biden administration’s antitrust campaign a concern for pharma
Last year, the Biden administration drafted an executive order that promoted competition in the U.S. economy across several industries, including pharma and biotech. The focus on the pharma industry was not surprising, given Biden’s campaign pledge to curb drug pricing. To that end, the Biden administration has explored a variety of approaches, according to Robin Adelstein, the…
CinCor’s COO has a mission to transform hypertension treatment
The clinical-stage biopharma CinCor is developing baxdrostat, a highly selective, oral small molecule inhibitor of aldosterone synthase, for hypertension. Catherine Pearce, chief operating officer and co-founder of CinCor, acknowledges that the company has received criticism for its plan to bring a new drug into the highly genericized blood pressure control market. “The reality is that…
Senator Warren and Senator-elect Welch accuse of Pfizer profiteering over planned COVID-19 vaccine price
In October, Pfizer (NYSE:PFE) signaled its plans to raise its COVID-19 vaccine price to roughly $110 to $130 per dose. The new price would go effect after the U.S. government’s purchase program for the vaccine expires, said Angela Lukin, Pfizer’s global primary care and U.S. president. Senator Warren and Senator-elect Welch asked Pfizer CEO Albert…