Please Wait
Applying Filters...
Menu
$ API Ref.Price (USD/KG) : 94Xls

Digital Content read-more

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

read-more
read-more
FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments
This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).  Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period.  Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.  

Impressions: 3514

https://www.pharmacompass.com/radio-compass-blog/fda-s-june-2024-list-of-off-patent-off-exclusivity-drugs-sees-rise-in-cancer-hiv-treatments

#PharmaFlow by PHARMACOMPASS
11 Jul 2024

STOCK RECAP #PipelineProspector

read-more
read-more
Pipeline Prospector Jan 2025: J&J’s US$ 14.6 bn Intra-Cellular buyout kicks off deal frenzy; Ozempic clinches FDA nod for CKD
January was a busy month that saw several deals being announced at the JP Morgan Healthcare Conference. In all, deals worth over US$ 19.3 billion were signed at the annual event. The month also saw several key drugs getting approved by the US Food and Drug Administration (FDA). This got reflected in the indices — while the Nasdaq Biotechnology Index (NBI) rebounded 4.42 percent to reach 4,532.75, the SPDR S&P Biotech ETF (XBI) and S&P Biotechnology Select Industry Index (SPSIBI) posted gains of 1.89 percent and 2.84 percent respectively.   Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)    J&J buys Intra-Cellular for US$ 14.6 bn, Lilly strikes US$ 2.5 bn cancer deal with Scorpion Johnson & Johnson (stock up 5 percent) announced the biggest biotech buyout since March 2023 with its acquisition of Intra-Cellular Therapies (stock up 49 percent), a neuroscience-focused biopharmaceutical company, for US$ 14.6 billion. Intra-Cellular’s lead drug, Caplyta (lumateperone), approved for bipolar depression, is undergoing FDA review for major depressive disorder (MDD).  Eli Lilly (stock up 5 percent) announced a US$ 2.5 billion deal to acquire Scorpion Therapeutics’ experimental cancer therapy, STX-478. This therapy targets specific mutations in breast cancer and other solid tumors. Lilly also partnered with UK-based Alchemab Therapeutics to develop up to five new antibodies targeting amyotrophic lateral sclerosis (ALS). Gilead Sciences (stock up 5 percent) and LEO Pharma teamed up in a deal worth up to US$ 1.7 billion to develop oral STAT6 inhibitors for inflammatory diseases. These inhibitors will target key pathways in conditions like atopic dermatitis, asthma, and COPD, offering a potential oral alternative to injectable biologics. GSK (stock up 6 percent) agreed to acquire IDRx, a Massachusetts-based developer of rare cancer therapies, for up to US$ 1.15 billion. IDRx focuses on treatments for gastrointestinal stromal tumors (GIST), rare cancers that develop in the digestive tract.   Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)   Ozempic becomes first GLP-1 to treat CKD in diabetes patients; Novo puts another US$ 4.6 bn in deal with Valo FDA approved Novo Nordisk’s Ozempic (semaglutide) to reduce the risk of kidney disease progression, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). This approval makes Ozempic the first glucagon-like peptide 1 (GLP-1) receptor agonist indicated for this patient population. This most broadly indicated GLP-1 drug is already approved for cardiovascular events. Novo also announced expansion of its collaboration with Valo Health to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular diseases. This partnership leverages Valo’s extensive human datasets and artificial intelligence capabilities.  The expanded agreement is potentially worth US$ 4.6 billion for up to 20 drug programs. Akero Therapeutics’ stock jumped 100 percent after data from its mid-stage trial showed that 39 percent of patients treated with a 50 mg dose of efruxifermin experienced reversal of cirrhosis with no worsening of metabolic dysfunction-associated steatohepatitis (MASH) after 96 weeks, compared to 15 percent in the placebo group. Meanwhile, FDA expanded the use of Eli Lilly’s Omvoh (mirikizumab)to include treatment for moderate-to-severe Crohn’s disease, bolstering the company’s immunology portfolio beyond its focus on obesity treatments.   Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)  AbbVie in US$ 1.64 bn molecular glue degraders deal with Neomorph; Galapagos splits into two AbbVie (stock up 8 percent) and Neomorph entered into a US$ 1.64 billion collaboration to develop molecular glue degraders targeting previously “undruggable” proteins in oncology and immunology. AbbVie also acquired an option to license Simcere Zaiming’s SIM0500, a novel trispecific antibody candidate for multiple myeloma, in a deal valued at up to US$ 1.06 billion. SIM0500 is currently in early-stage clinical trials in both China and the US. Boehringer Ingelheim has expanded its oncology pipeline with two licensing deals. First, the company partnered Synaffix in a deal worth up to US$ 1.3 billion to advance antibody-drug conjugates (ADCs). Second, it exercised the option to gain rights to a fourth novel cancer target from an ongoing discovery collaboration with Oxford BioTherapeutics, which began in 2013. Sanofi (stock up 10 percent) announced plans to buy back € 5 billion (US$ 5.21 billion) in shares in 2025, signaling potential increases in acquisition activities following the sale of its Opella consumer health unit. This divestment marks Sanofi’s shift to focusing exclusively on drugs and vaccines. Galapagos (stock down 18 percent) announced plans to split into two distinct publicly traded entities. The entity that retains the Galapagos name will focus on advancing its cell therapy programs in oncology, while the other one will focus on developing a pipeline of innovative medicines through strategic transactions. It will be capitalized with approximately € 2.45 billion (US$ 2.53 billion) from Galapagos’ current cash reserves.   Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)  J&J’s Spravato approved for depression by FDA; another Astra-Daiichi ADC sees light of day The psychedelic medicine frontier showed promise with J&J’s Spravato (esketamine) achieving a breakthrough as FDA approved it for treatment-resistant depression (standalone treatment). The nasal spray demonstrated impressive efficacy, with 22.5 percent of patients achieving remission by week four.  Atai Life Sciences also announced encouraging results from a mid-phase study evaluating BPL-003, an intranasal formulation of 5-MeO-DMT benzoate in patients with moderate to severe alcohol use disorder (AUD). In oncology, AstraZeneca (stock up 9 percent) and Daiichi Sankyo (stock up 3 percent) secured US approval for Datroway (datopotamab deruxtecan) for treating unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer. Meanwhile, Amgen’s combination therapy of Lumakras (sotorasib) with Vectibix (panitumumab) received FDA approval for KRAS G12C-mutated metastatic colorectal cancer. Amgen’s stock gained 9 percent. FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine), a first-in-class non-opioid oral pain signal inhibitor. This approval marks the first new class of pain medicine in over 20 years, offering an effective alternative without addictive potential. The US agency also approved Axsome Therapeutics’ rapid-acting Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine.   Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)  Our view If 2024 ended with a spate of drug approvals, 2025 began with both increased dealmaking and approvals. However, post January 20, the world is a different place. Trump administration’s tariff policies have spurred a trade war, and China has retaliated with tariffs of US coal and gas. At present, there is little certainty on what the tariffs mean for different pharma companies, especially those who don’t manufacture in the US. While some drugmakers are hopeful that Trump will crack down on the pharmacy benefit managers, others are more concerned on what higher tariffs on EU and Indian drugmakers would mean for generic drug prices. We expect volatility for at least some months.  Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)  

Impressions: 3217

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-jan-2025-j-j-s-us-14-6-bn-intra-cellular-buyout-kicks-off-deal-frenzy-ozempic-clinches-fda-nod-for-ckd

#PharmaFlow by PHARMACOMPASS
06 Feb 2025

NEWS #PharmaBuzz

read-more
read-more

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-axsome-therapeutics-migraine-drug-2025-01-30/

REUTERS
31 Jan 2025

https://www.prnewswire.com/news-releases/heron-therapeutics-announces-fda-approval-of-the-prior-approval-supplement-application-for-zynrelef-vial-access-needle-van-302258083.html

PR NEWSWIRE
25 Sep 2024

https://www.globenewswire.com/news-release/2024/09/04/2940340/33090/en/Axsome-Therapeutics-Announces-FDA-Acceptance-of-NDA-Resubmission-for-AXS-07-for-the-Acute-Treatment-of-Migraine.html

GLOBENEWSWIRE
04 Sep 2024

https://www.prnewswire.com/news-releases/heron-therapeutics-announces-the-inclusion-of-zynrelef-as-a-qualifying-product-under-the-proposed-2025-non-opioid-policy-for-pain-relief-under-the-opps-and-the-asc-payment-system-302196793.html

PR NEWSWIRE
15 Jul 2024

https://www.prnewswire.com/news-releases/heron-therapeutics-announces-acceptance-of-the-prior-approval-supplement-application-for-zynrelef-vial-access-needle-van-302187706.html

PR NEWSWIRE
02 Jul 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217579

FDA
07 Jun 2023