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DATA COMPILATION #PharmaFlow

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US drug shortages hit record high in Q1 2024, impacts cancer, ADHD drugs; Lilly, Novo ramp up production
Drug shortages are threatening healthcare systems the world over. Be it the US, Canada, Europe or Africa, drug scarcities are straining healthcare systems and costing lives.In the US, the first quarter (Q1) of 2024 saw a staggering 323 drug shortages, the highest number recorded since the American Society of Health-System Pharmacists (ASHP) began tracking such data in 2001. However, Q2 2024 saw active drug shortages reduce to 300 drugs.While the shortages span a wide range of medications, five categories have been severely impacted in the US — central nervous system drugs, antimicrobials, hormone agents, injectable fluids and electrolytes, and chemotherapy drugs. Other critical medications in short supply include drugs to treat attention deficit hyperactivity disorder (ADHD).View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available)Chemo scarcities spark concerns; vaccine shortage hampers mpox response in AfricaIn the US, shortage of at least 21 chemotherapy drugs has impacted cancer treatments. A survey undertaken by the National Comprehensive Cancer Network found 89 percent of participating centers reporting shortages of at least one critical systemic anticancer therapy. These included drugs like vinblastine, etoposide and topotecan. Since early 2023, supply issues have led to what’s now known as the “carboplatin shortage”, a key platinum-based chemo drug that is impacting cancer treatment. Carboplatin is crucial for treating various cancers, including ovarian, lung, and breast cancer.The good news is that there has been a reduction in shortages of platinum-based chemo drugs such as carboplatin and cisplatin. In fact, the FDA website now mentions the shortage of cisplatin as resolved. However, the shortage of carboplatin persists.Meanwhile, Africa is facing an acute shortage of diagnostic kits, treatments and vaccines to fight the outbreak of monkeypox (mpox). The Africa Centers for Disease Control and Prevention estimates it would need 10 million vaccines to stop the outbreak. Bavarian Nordic’s Jynneos is currently the only widely approved mpox vaccine, and countries like the US, Spain, France and Germany have pledged doses of Jynneos to help Africa fight the outbreak.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) Drug shortages impacts ADHD patients in US; Canada implements tiered systemThe US Food and Drug Administration (FDA) first reported a shortage of Adderall, a common ADHD treatment, in October 2022. Since then, the shortage has spread to other crucial medications like Ritalin, Vyvanse, and Focalin. This is a significant issue for the roughly 10 million adults and six million children in the US who rely on such drugs to manage their ADHD symptoms.An already concerning shortage of ADHD medications in the US has the potential to worsen due to some recent events. The Centers for Disease Control and Prevention (CDC) issued a health advisory in June, warning that the arrest of two telehealth executives from Done Global, a digital health company, could exacerbate the ADHD medication shortage. Done Global was accused of illegally distributing Adderall online. The arrests could disrupt care not only for Done Global patients but also for those who use other telehealth services.Meanwhile, Canada has implemented a tiered system for addressing drug shortages, with tier 3 shortages being those with the greatest potential impact on the country’s drug supply and healthcare system. Currently, there are 20 drugs listed under tier 3.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) GLP-1 drug shortages create US$ 1 bn shadow industry; Lilly, Novo expand capacitiesThe shortage of glucagon-like peptide-1 (GLP-1) receptor agonists, such as Ozempic, Saxenda, Trulicity, Victoza, Mounjaro, and Zepbound, has been grabbing headlines. These drugs are used in the treatment of diabetes and in weight management.The shortage of these drugs has led to a surge in demand for compounded versions of these medications, creating both opportunities and significant risks. While the FDA’s Food, Drug, and Cosmetic Act allows it to turn a blind eye to pharmacists producing and selling non-approved compounded versions under certain circumstances, this practice has led to a billion-dollar shadow industry of compounded GLP-1 drugs.Eli Lilly has discovered compounded drugs advertised as tirzepatide (Mounjaro and Zepbound) with significant safety, sterility, and efficacy issues. In response to the safety risks, Lilly has taken legal action against several wellness centers, medical spas, and other sellers in the US.To address the supply issues, Lilly has announced its largest manufacturing investment yet, investing an additional US$ 5.3 billion at its Indiana site. Similarly, Novo Nordisk’s parent company is acquiring Catalent for US$ 16.5 billion to increase Wegovy production. Novo is also investing US$ 4.1 billion to develop a new manufacturing facility in Clayton, North Carolina (US).The FDA website continues to list Novo and Lilly’s GLP-1 drugs as “Currently in Shortage”, even though the drugmakers say otherwise. The EMA website says the shortage of Novo’s Wegovy has been resolved but Lilly’s Trulicity and Novo’s Saxenda continue to be in shortage.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) FDA works closely with cancer drugmakers; France introduces roadmap to address drug shortagesApart from pharma companies, health authorities and governments are also taking steps to reduce drug shortages. FDA is working closely with five cancer drug manufacturers to increase production capacities. It has also facilitated the re-entry of a previously discontinued cisplatin product into the market.On the legislative front, the US Senate Finance Committee has proposed a draft of a policy that would incentivize generic drug manufacturers to prioritize production of essential medications. These incentives include minimum three-year contracts with stable pricing, contingency contracts with alternate manufacturers, transparency in quality control issues, and modifications to the Medicaid Drug Rebate Program. France, like most European nations, is also facing shortages of medicines like insulin and anti-cancer drugs. But most problematic are its shortages of antibiotics, paracetamol and corticoids. The French government has introduced a new three-year "roadmap" (from 2024 to 2027) to address these shortages. A significant step in this direction is the planned opening of the first European paracetamol factory in Toulouse in 2025, which will help reduce Europe’s dependence on China, India, and the US for this widely used medication.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) Our viewThe global drug shortages underscore the fragility of pharmaceutical supply chains and the urgent need for reform. Longstanding drug shortages, particularly those affecting cancer treatments, antibiotics, and essential medications often stem from the low profitability of generic drugs.While investments in manufacturing capacity and regulatory measures are steps in the right direction, a more comprehensive, concerted global approach is needed to resolve the deep-seated systemic issues in the pharmaceutical industry.  

Impressions: 3126

https://www.pharmacompass.com/radio-compass-blog/us-drug-shortages-hit-record-high-in-q1-2024-impacts-cancer-adhd-drugs-lilly-novo-ramp-up-production

#PharmaFlow by PHARMACOMPASS
29 Aug 2024

STOCK RECAP #PipelineProspector

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Pipeline Prospector Dec 2022: Biotech indices fall on close of a volatile year
The year 2022 was a difficult one for the biotech sector. Marked with geopolitical unrest, rising interest rates, the Russian-Ukraine war, inflation, and most of all, a stricter regulatory environment, biotech companies had a tough going. Biotech stocks were on a roller coaster ride through the year, with the first few months witnessing bearish trends. The sector bounced back in the second half of 2022 due to M&A deals, strong earnings performance, new drug approvals and pipeline successes. But the joy was short-lived – the indices dipped once again in December.The Nasdaq Biotechnology Index (NBI) fell 3.4 percent to US$ 4,213. In November, it was up 5 percent. There was no change in the S&P Biotechnology Select Industry Index (SPSIBI) last month. It was up 1.1 percent in November. And the SPDR S&P Biotech ETF (XBI) rose 0.1 percent in December, as opposed to 1 percent rise in November.For the full year, NBI fell 11 percent, while both SPSIBI and XBI plummeted 28 percent. Overall though, biotech companies can take heart from the fact that 2022 was the worst year for S&P 500 and Nasdaq Composite since 2008.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel)Novo gains post Wegovy launch in Denmark; Sanofi’s stock rises post legal winDecember was a big month for Novo Nordisk as the Danish drugmaker launched its diabetes drug Wegovy (semaglutide) in its home market, fulfilling its promise to launch the med outside of the US by 2022-end. Wegovy also received an add-on approval from the US Food and Drug Administration (FDA) to treat obesity in teens 12 years and above just before Christmas. All the good news resulted in an 8 percent rise in Novo’s stock. Another mega cap company that made gains on the bourses last month was French drugmaker Sanofi — its stock rose 7 percent. A big reason behind this was the dismissal of about 50,000 lawsuits by a US district judge. The lawsuits had claimed that the heartburn drug – Zantac – causes cancer. Shares of GSK and Sanofi also made gains due to the dismissal, adding more than US$ 20 billion in combined value soon after the court’s decision. Sanofi’s blockbuster dermatitis and asthma drug Dupixent (dupilumab) also received marketing authorization in Europe as the first and only targeted medicine for prurigo nodularis, a chronic and debilitating skin disease.In early 2022, Novo had faced supply bottlenecks for Wegovy. Last month, its chief rival Eli Lilly met the same fate as it failed to meet the demand for its newly approved diabetes injection Mounjaro (tirzepatide). FDA added Mounjaro to its list of drugs facing shortages, along with a second diabetes med, Trulicity (dulaglutide). Lilly’s stock was down 2 percent in December.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) FDA’s Aduhelm nod gets flayed post probe; Roche suspends Alzheimer’s drug trialIt wasn’t a good month for Biogen, whose stock dropped by 9 percent in December. Three patient deaths got linked with Eisai and Biogen’s second Alzheimer’s drug — Leqembi (lecanemab). And, towards the end of the month, there was news that an 18-month-long investigation conducted by two House of Representatives’ committees found FDA’s approval process of Biogen’s controversial Alzheimer’s disease drug — Aduhelm (aducanumab) — to be “rife with irregularities”.There was more bad news on drugs for Alzheimer’s. Roche (down 2 percent) decided to suspend most trials of its Alzheimer’s drug – gantenerumab – after it failed to slow advancement of the disease in late-stage studies. In another setback to the Swiss drugmaker, a combination of Tecentriq (atezolizumab) and Exelixis-Ipsen’s Cabometyx (cabozantinib) failed to meet the primary endpoint in a phase 3 lung cancer trial. Ipsen’s stock fell 6 percent.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Madrigal zips past rivals in NASH race; Prometheus’ colitis drug posts trial winAmong mid-cap companies, Pennsylvania-based Madrigal Pharmaceuticals’ shares soared by over 300 percent in December after its experimental drug to treat nonalcoholic steatohepatitis (NASH) – resmetirom – met the main goal in a late-stage study. The trial’s success has propelled Madrigal to the forefront of a race to develop the first treatment for NASH, a form of non-alcoholic fatty liver disease. Madrigal plans to move FDA for an accelerated approval of resmetirom this year.Another mid-cap company Prometheus Biosciences saw its stock soar 171 percent after its lead drug candidate – PRA023 – met the endpoints in a phase 2 study in patients with moderate-to-severely active ulcerative colitis.A small cap company named Icosavax saw its stock soar 125 percent after it announced a positive outcome for its respiratory syncytial virus (RSV) vaccine from a phase 1/1b study. Icosavax is a US-based, clinical stage vaccine company. A single dose of the shot, IVX-121, demonstrated a response against RSV that lasted six months.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Horizon’s stock rises after Amgen acquires it for US$ 27.8 billionThe biggest biopharma deal of 2022 was Amgen’s acquisition of Horizon Therapeutics for US$ 27.8 billion. News of Amgen and Sanofi’s buyout interest in Horizon had led to a 61 percent rise in the rare disease drugmaker’s stock in November. Last month, Horizon’s shares increased by 10 percent after Amgen finally announced the acquisition.Another significant deal inked in December was Japanese drugmaker Takeda’s (up 7 percent)  acquisition of  Nimbus Therapeutics’ experimental psoriasis drug for up to US$ 6 billion. This is Takeda’s biggest buyout since it purchased Shire for US$ 62 billion in 2019. The deal is also among the pharma industry’s largest single-asset purchases since Amgen bought Otezla from Celgene in 2019 for US$ 13.4 billion.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Moderna’s mRNA vaccine-Keytruda combo succeeds in mid-stage skin-cancer trialA combination of Moderna’s experimental messenger RNA cancer vaccine and Merck’s blockbuster immunotherapy Keytruda (pembrolizumab) was successful in a mid-stage skin cancer trial. Moderna’s stock grew 19 percent following the news, but it nosedived soon after. Merck is also carrying out clinical trials of Keytruda that can be injected under the skin. The drugmaker is testing at least two versions of the drug in the hope that a new formulation will allow it to retain the drug’s patent edge and protect it from competition.Novartis’ stock reported a 2 percent growth in December. Its drug Pluvicto showed survival benefits in a late-stage prostate cancer trial. Its rare blood disease drug iptacopan was also successful in treating paroxysmal nocturnal hemoglobinuria in a late-stage trial.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Our viewSoothsayers do not have positive things to say about 2023. The Ukraine-Russia war has played havoc with food and energy costs, causing the highest rates of inflation. And a global recession seems inevitable in 2023.Even as the world grapples with these challenges, innovation is likely to save the day for the biotech sector. In 2023, Eisai and Biogen’s Leqembi became the first drug to receive an accelerated approval from the FDA. Several other pathbreaking drugs will come up for approval this year, including vaccines and therapies for RSV, new treatments for Alzheimer’s disease, a gene therapy for Duchenne muscular dystrophy and several treatments for obesity. The heady mix of recession and innovation may also trigger more M&A activity. And we hope these innovations result in a better year for the sector.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) 

Impressions: 1688

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-dec-2022-biotech-indices-fall-on-close-of-a-volatile-year

#PharmaFlow by PHARMACOMPASS
12 Jan 2023

NEWS #PharmaBuzz

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https://www.prnewswire.com/news-releases/head-to-head-superiority-over-dulaglutide-innovents-phase-3-clinical-trial-dreams-2-of-mazdutide-in-chinese-patients-with-type-2-diabetes-were-orally-presented-at-easd-2024-302244860.html

PR NEWSWIRE
11 Sep 2024
Lilly's next-gen obesity drug brings Innovent ph. 3 diabetes win
Lilly's next-gen obesity drug brings Innovent ph. 3 diabetes win

09 May 2024

// James Waldron FIERCE BIOTECH

https://www.fiercebiotech.com/biotech/lillys-next-gen-obesity-drug-brings-innovent-phase-3-win-diabetes

James Waldron FIERCE BIOTECH
09 May 2024

https://www.prnewswire.com/news-releases/head-to-head-superiority-to-high-dose-dulaglutide-innovents-first-phase-3-clinical-trial-of-mazdutide-in-chinese-patients-with-type-2-diabetes-met-study-endpoints-302139839.html

PR NEWSWIRE
08 May 2024

https://www.reuters.com/business/healthcare-pharmaceuticals/most-doses-lillys-mounjaro-zepbound-limited-availability-us-fda-says-2024-04-17/

REUTERS
17 Apr 2024

https://www.theguardian.com/global-development/2024/mar/28/drug-companies-diabetes-drugs-medicines-ozempic-trulicity

Kat Lay THEGAURDIAN
28 Mar 2024
UK probes GLP-1 drugs' potential suicide risks
UK probes GLP-1 drugs' potential suicide risks

27 Jul 2023

// Angus Liu FIERCE PHARMA

https://www.fiercepharma.com/pharma/glp-1-drugs-novo-az-lilly-and-sanofi-under-uk-probe-over-their-suicide-risks-reuters

Angus Liu FIERCE PHARMA
27 Jul 2023