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FDA approvals slump 19% in H1 2024; NASH, COPD, PAH get new treatment options

The first half of 2024 saw a significant slowdown in approvals of new drugs and biologics by the US Food and Drug Administration (FDA) compared to the same period last year.FDA’s Center for Drug Evaluation and Research (CDER) approved 21 drugs in H1 2024, reflecting a 19 percent decrease from the 26 approvals granted in H1 2023. Of them, 81 percent (17) were first-in-class drugs (therapies that use a new and unique mechanism of action), while small molecules made up for 67 percent (14) of the total drugs approved.Similarly, the Center for Biologics Evaluation and Research (CBER) granted approvals to only eight biologics, as compared to 10 in H1 2023.Health Canada also saw a drop in drug approvals as only 10 drugs were okayed in H1 2024, as opposed to 13 approvals in H1 2023.The European Medicines Agency (EMA) saw a marginal rise in drug authorizations at 15 for H1 2024 as compared to 14 approvals in H1 2023. Interestingly, the EMA also saw a surge in pending decisions (applications under review) — from two in H1 2023 to 14 in H1 2024.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available)Merck, Madrigal, Verona bag approvals for breakthrough meds; Lilly’s donanemab okayedThe first half saw some closely watched drugs win regulatory approvals. FDA approved a breakthrough therapy from Merck — Winrevair (sotatercept) — that treats adults with hypertension caused by the constriction of arteries in the lungs, known as pulmonary arterial hypertension (PAH).Merck had acquired Winrevair through its US$ 11.5 billion acquisition of Acceleron Pharma in 2021. The therapy is set to generate nearly US$ 3 billion in global peak sales by 2028. Another breakthrough therapy approved in H1 2024 is Madrigal’s Rezdiffra (resmetirom), the first FDA-approved treatment for adults with the common fatty liver disease — nonalcoholic steatohepatitis (NASH). Rezdiffra is expected to touch sales of US$ 2.1 billion by 2028.The agency also approved the first maintenance treatment for chronic obstructive pulmonary disease (COPD) in over 20 years — Verona’s Ohtuvayre. The drug has a novel mechanism of action and is the first inhaled maintenance treatment for COPD. Approved in June by the FDA, Ohtuvayre is forecast to bring in global sales of US$ 1.5 billion by 2030.The approval of Eli Lilly’s donanemab was surprisingly delayed, and finally came through on July 2 after an FDA advisory committee voted unanimously in favor of its benefits outweighing its risks. To be sold as Kinsula, the Alzheimer's drug is estimated to bring in US$ 2.2 billion in sales by 2028.Across the pond, EMA approved Novo Nordisk’s weekly insulin injection Awiqli (insulin icodec). The replacement insulin in Awiqli acts in the same way as the body’s own insulin and helps glucose enter cells from the blood. Meanwhile, FDA rejected this once-a-week insulin earlier this month and has requested information related to the manufacturing process.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) ImmunityBio, Geron, Day One win approvals for their oncology drugsIn what marks the first approval for ImmunityBio, FDA greenlit Anktiva (nogapendekin alfa inbakicept-pmln) as part of a combination therapy to treat a type of bladder cancer. Anktiva is a next-generation immunotherapy that creates long-term immunity by activating the so-called natural killer (NK) cells and T-cells. It will compete with Merck’s Keytruda. Anktiva’s yearly sales by 2030 are expected to be around US$ 1.7 billion.BeiGene’s PD-1 blocker Tevimbra (tislelizumab) got the go-ahead from the FDA as the treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Tevimbra’s 2028 global sales are forecast to bring in US$ 1.6 billion.FDA signed off on Geron’s Rytelo (imetelstat) for treating transfusion-dependent anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers. This was Geron’s maiden approval and Rytelo is expected to bring in US$ 1.3 billion by 2030.Day One Biopharmaceuticals’ Ojemda (tovorafenib) was granted FDA’s accelerated approval to treat certain types of pediatric brain cancer. This is the first FDA approval of a systemic therapy for treating what is the most common form of childhood brain tumor, including fusions. Ojemda is forecast to bring in US$ 1 billion in sales by 2030.FDA granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adults in advanced stages of small cell lung cancer (SCLC) that has proven to be hard to treat or has worsened despite platinum-based chemotherapy. Imdelltra is expected to bring in annual sales of US$ 975 million by 2030.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Infectious disease drugs from Basilea, Merck, rare disease med from Ipsen bag approvalsAfter oncology, infections and infectious diseases, and rare diseases were the two therapeutic areas that saw the second and third most approvals, respectively. FDA approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium for injection), an antibiotic for bacterial infections including multidrug-resistant strains.The US agency also approved Merck’s next-generation vaccine designed to protect adults from pneumococcus bacteria that causes serious illnesses and pneumonia. The jab, known as Capvaxive, helped produce an immune response against all 21 variations (serotypes) of the bacteria that it targeted. These 21 strains account for about 85 percent of invasive pneumococcal disease cases in adults aged 65 and above. FDA also approved Moderna’s mRESVIA, a messenger RNA-based (mRNA) respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by the syncytial virus. This is the first non-Covid mRNA vaccine to be approved in the US.The agency granted accelerated approval to Ipsen’s Iqirvo (elafibranor) to treat primary biliary cholangitis (PBC), a rare liver disease. This is the first new medicine approved in nearly a decade for the treatment of PBC. Orchard Therapeutics’ Lenmeldy secured FDA approval to become the first gene therapy in the US for a rare pediatric disorder, known as metachromatic leukodystrophy (MLD). The debilitating hereditary disease affects the brain and the nervous system and causes loss of cognitive and motor functions and early death.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Our viewThe increased momentum of drug approvals witnessed after the pandemic appears to have slowed down, but what’s encouraging is the increase in first-in-class therapies, cancer drugs and promising new treatment options for a range of conditions such as PAH, NASH, and COPD.The second half has already kicked off with the approval of Lilly’s donanemab. And there are several pathbreaking drugs likely to be approved soon, such as Karuna Therapeutics’ schizophrenia drug KarXT and BridgeBio’s heart drug acoramidis. There is every possibility that new drug approvals will spring back up in H2 2024.

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25 Jul 2024

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Drop in Covid sales, trial failures, restructuring trigger steep rise in layoffs in Q1 2023

Since 2022, layoffs have become commonplace. The ongoing global banking crisis, coupled with pre-existing factors such as the Ukraine-Russia conflict, inflation, looming recession and rising interest rates have made the business environment even more volatile and daunting. The kinks in the supply chain got exacerbated by China’s Covid policy. And all these economic challenges compelled companies to retrench employees the world over. While the surge in layoffs has been more apparent in the technology sector, the pharma sector has also been facing the headwinds.Though the biopharma sector has experienced significant growth due to new technologies such as gene editing, cell therapy, messenger RNA and the Covid-19 vaccines and therapies, some drugmakers began to see revenues of their Covid products fall significantly with a drop in cases.However, job cuts in the pharma industry aren’t limited to companies that make Covid products. Several others have announced job cuts citing restructuring, trial failures and holds, termination of deals, facility shutdowns and reprioritization of projects.In the first quarter (Q1) of 2022, we saw around 30 pharma companies announce layoffs. In Q1 of 2023, the corresponding number went up to over 50. Overall, more than 100 biopharma companies had announced layoffs in 2022.View Biopharma Layoff Tracker: 2022–Mid April '23 (Free Excel Available)Pandemic-hit Grifols to cut 2,300 jobs; Catalent, Thermo Fisher lay off hundredsSpanish pharma Grifols has announced the biggest layoff of 2023 so far — it plans to axe 8.5 percent of its global workforce, or around 2,300 employees, to save €400 million (US$ 427 million) annually. The Covid-19 pandemic dealt a severe blow to its plasma-derived medicines as blood collection collapsed around the world in 2020 and 2021. The drugmaker is now working on a “more efficient” platform to obtain plasma and reduce its expenses.French vaccine maker Valneva said it will lay off 20 to 25 percent of its workforce in order to save US$ 12 million. Valneva cited clinical trial costs and expedited winding down of Covid vaccine-related activities as reasons behind the layoffs. Some CDMOs have been hit equally badly. For instance, Catalent, which has played a critical role in producing Covid-19 vaccines and therapies, has cut around 600 jobs across multiple facilities in the US, and Thermo Fisher Scientific, a producer of Covid testing kits, has laid off around 500 employees across various locations in California between January 2022 and the middle of April 2023.Meanwhile, US-based Axcella said it will lay off 85 percent of its staff as it ended work on its NASH program to focus on developing a long Covid therapy. Last July, another US company, Inovio, said it will cut 18 percent of its workforce due to its troubled Covid program. And this year, it plans to downsize again and focus on its human papillomavirus (HPV) program.View Biopharma Layoff Tracker: 2022–Mid April '23 (Free Excel Available)Novartis to cut up to 8,000 jobs, J&J to downsize as part of restructuringBig pharma companies such as Novartis and Johnson & Johnson (J&J) have announced plans to restructure their businesses, and job cuts are a part of that exercise. In April 2022, Novartis announced plans to save at least US$ 1 billion by 2024 by combining its pharmaceuticals and oncology business units to form a new Innovative Medicine unit with the goal of achieving sales growth of at least 4 percent through 2026. It also revealed plans to spin off Sandoz to focus on patented prescription medicines. As a result of these changes, the Swiss drugmaker announced plans to eliminate up to 8,000 jobs.Novartis is moving ahead with the job cuts and has announced plant closures in the US. In addition, Novartis slashed 400 jobs in India following a new sales and distribution agreement with Dr. Reddy’s Laboratories.Similarly, as J&J moves ahead with plans to spin off its consumer health, it is cutting jobs. J&J is also restructuring the infectious disease and vaccine groups of its Janssen division and has planned global layoffs. Fate Therapeutics, a former partner of J&J, laid off 315 staff after ending its agreement with the company. Gilead has also cut jobs at the former Immunomedics headquarters in New Jersey and relocated the site to a larger space with no manufacturing.View Biopharma Layoff Tracker: 2022–Mid April '23 (Free Excel Available)Merck, BMS cut staff at acquired companies; Biogen downsizes due to Aduhelm, TecfideraMany retrenchments in the biopharma sector have been a result of acquisitions. Merck laid off around 143 employees from its Acceleron division in Cambridge, Massachusetts, shortly after acquiring the Boston-based company for US$ 11.5 billion in March 2022.BMS has also laid off 261 employees across two San Diego sites following its acquisition of Turning Point Therapeutics for US$ 4.1 billion. Similarly, US biotech Flexion Therapeutics laid off 110 employees, after being acquired by Pacira BioSciences. Six months after acquiring Kadmon Holdings, Sanofi is closing its Kadmon New York facility and laying off 25 employees. Sanofi-Aventis Korea is reducing its workforce through a voluntary retirement scheme. And AbbVie laid off 99 staffers from a single facility in Irvine (California), which was once an Allergan facility (a company it acquired in 2019 for US$ 63 billion).In 2022, Amgen made some high-value acquisitions and agreements – it bought rare disease drugmaker, Horizon Therapeutics, for US$ 27.8 billion and ChemoCentryx for US$ 4 billion as part of its growth strategy. But this year, Amgen has announced layoffs on two occasions, retrenching a total of around 750 employees to realign its expenses in the face of intensifying pressure on drug prices and high inflation. And Roche’s Genentech unit has shut down operations at its production facility in South San Francisco, laying off 265.In December 2021, Biogen had announced plans to lay off up to 1,000 staffers in an effort to cut about US$ 500-750 million in costs following the lower-than-expected sales of its controversial Alzheimer’s disease drug, Aduhelm, This year, Biogen has trimmed its multiple sclerosis team due to generic competition to its blockbuster drug Tecfidera. The job cuts were necessitated after the company failed to defend the market exclusivity of the drug through several lawsuits in the US.Japanese drugmakers Daiichi Sankyo and Eisai have shut down their R&D units in the US. While Daiichi has closed its R&D unit in San Francisco that employed 60 people, Eisai has closed its oncology R&D wing in the US, H3 Biomedicine, a move that has resulted in the loss of 88 jobs.View Biopharma Layoff Tracker: 2022–Mid April '23 (Free Excel Available)Drug rejections, trial failures lead to job cuts at Akebia, Y-mabs, SpectrumSeveral companies, such as Akebia, Y-mabs, Spectrum, have laid off sizable portions of their workforce due to drug rejections by the US Food and Drug Administration (FDA). Akebia laid off 42 percent of its workforce after FDA rejected its anemia drug vadadustat. Similarly, Spectrum laid off most of its R&D team after FDA rejected its drug poziotinib in November 2022. In January 2022, it had terminated 30 percent of its workforce. The same was the case with Y-mabs — a substantial number of employees lost their jobs after FDA rejected its drug omburtamab. In April 2022, Bluebird bio reduced its workforce by 30 percent to cut costs. Its gamble paid off as the FDA approved two of its cell and gene therapies – Skysona and Zynteglo – a few months later.Meanwhile, Galapagos dropped its kidney and fibrosis programs to focus on oncology and immunology candidates, laying off around 200 staffers. And disappointing data from a late-stage trial of its drug for symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) — avramidis — forced BridgeBio to announce retrenchment of an undisclosed number of employees last year.View Biopharma Layoff Tracker: 2022–Mid April '23 (Free Excel Available)Our viewThe biopharma industry grew impressively in 2022. Our analysis of combined (global) revenues of 15 leading (randomly selected) drugmakers in 2021 and 2022 reveals an impressive growth in revenues of around 7 percent. However, in 2023, a third of these drugmakers expect a drop in revenues, with Pfizer expecting its turnover to drop by over 30 percent this year. The reduced guidance may result in more layoffs.As we move into Q2, the layoff trend continues unabated. Last month, Thermo Fisher announced it will lay off 218 employees at three of its locations in San Diego, California, due to reduced demand for its Covid-19 products. These facilities will close in June. Japanese drugmaker Sumitomo and its subsidiary Sunovion Pharmaceuticals have announced plans to lay off 223 workers.The current business environment is not likely to cheer the job market. We have to wait for the cycle to turn.

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04 May 2023

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