Pharma Stock Roundup: FDA and EMA Regulatory Updates for ABBV, LLY, SNY & MRK ’s Drugs
This week, the European Commission granted marketing approval to AbbVie’s ABBV Tepkinly (epcoritamab) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The FDA approved Lilly’s LLY diabetes drug, Jardiance (empagliflozin), for expanded use in chronic kidney disease…#europeancommission #abbvies #fda #lilly #lly #sanofi #dupixent #merck #pah #jnj (Source: Reuters: Health)
Source: Reuters: Health - September 30, 2023 Category: Consumer Health News Source Type: news
Seagen Pops After Scoring A'Must-Win' For Its $43 Billion Pfizer Takeover
A bladder cancer treatment tied to a quartet of biopharma companies — including Pfizer (PFE) and buyout target Seagen (SGEN) — succeeded in a final-phase study on Friday, leading SGEN stock to surge. The companies added Merck's (MRK) Keytruda on top of Seagen and Astellas Pharma's (ALPMY) Padcev…#pfe #sgen #merck #seagen #astellaspharma #alpmy #isi #umerraffat #pfizer #padcev (Source: Reuters: Health)
Source: Reuters: Health - September 23, 2023 Category: Consumer Health News Source Type: news
Merck and Eisai say two lung-cancer trials failed to meet their main goals
Merck and Japanese partner Eisai said Friday that two late-stage trials of a treatment for a certain type of non-small lung cancer failed to meet their primary goals in a disappointing outcome, but said they would continue to push ahead with their research. The companies said the LEAP-006 and…#merck #eisai #keytruda #lenvima #nsclc #gregorylubiniecki #rcc (Source: Reuters: Health)
Source: Reuters: Health - September 22, 2023 Category: Consumer Health News Source Type: news
FDA Approves New and Updated Indications for Temozolomide Under Project Renewal
On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2023 Category: Drugs & Pharmacology Source Type: news
With the Decongestant SNAFU, the FDA Tries Something New
It’s easy to understand how a medicine like phenylephrine got onto pharmacy shelves in the first place. The common decongestant, used most often as an ingredient in multidrug cold medications like DayQuil and Sudafed PE, was initially designated as “safe and effective” by the Food and Drug Administration (FDA) in 1976, when the agency was newly—and less stringently than today—greenlighting drugs that had been on the market for years before the agency had established any efficacy standards. After a full review of 14 studies (12 unpublished and two published) from pharmaceutical companies—...
Source: TIME: Health - September 14, 2023 Category: Consumer Health News Authors: Haley Weiss Tags: Uncategorized healthscienceclimate Source Type: news
FDA approves new and updated indications for temozolomide under Project Renewal
On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meani (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 14, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Hipgnosis to Sell Song Catalogs Worth $465M to Boost Stock, Reduce Debt
Hipgnosis Songs Fund’s board of directors said on Thursday that the music royalty fund founded by Merck Mercuriadis plans to sell two portions of its song catalog in a bid to increase its stock price and pay down debt. The proposed sales include one package of assets that consists of 29 catalogs…#hipgnosissongsfunds #merckmercuriadis #blackstone #hipgnosissongsfund #kobalt #concord #netpublishershare #londonstockexchange #hipgnosissongfund #rollingstones (Source: Reuters: Health)
Source: Reuters: Health - September 14, 2023 Category: Consumer Health News Source Type: news
Moderna Surges After Flu Shot Beats Out Widely Used Sanofi, GSK Vaccines
stock popped Wednesday after the company said its experimental flu shot outperformed broadly used vaccines from Sanofi and GSK. The company pitted its messenger-RNA-based flu shot against Sanofi's (SNY) Fluzone and GSK's (GSK) Fluarix. All three vaccines aim to block four strains of influenza. In…#sanofi #gsk #messengerrna #moderna #pfe #bntx #fda #jameymock #merck #stephanebancel (Source: Reuters: Health)
Source: Reuters: Health - September 13, 2023 Category: Consumer Health News Source Type: news
Trial Shows Keytruda With Chemotherapy Superior to Chemo Alone
Results of a new phase 3 clinical trial published in the Journal of Clinical Oncology indicate that a chemoimmunotherapy regimen combining chemotherapy with immunotherapy drugs improves patient survival more than chemotherapy alone for pleural mesothelioma.
Study researchers used pembrolizumab (Keytruda) alongside platinum and pemetrexed chemotherapy. Christina S. Baik, MD, MPH, reviewed the phase 3 trial results during the American Society of Clinical Oncology’s 2023 Best of ASCO Seattle annual meeting.
The overall response rate for patients receiving Keytruda with chemotherapy was 63% compared to 40% for th...
Source: Asbestos and Mesothelioma News - September 13, 2023 Category: Environmental Health Authors: Fran Mannino Tags: Chemotherapy/Chemo drugs Immunotherapy Mesothelioma Treatment Source Type: news
AI medical capabilities show accuracy in clinical decision making
A striking new study from Mass General Brigham revealed that ChatGPT is nearly 72 percent accurate in making medical decisions, including identifying possible diagnoses and final care decisions. OPENAI, CREATOR OF CHATGPT, ON TRAJECTORY TO BRING IN $1 BILLION Some critics argue that artificial…#massgeneralbrigham #chatgpt #marcsiegel #newyorkuniversity #bigmoneyshow #merck #healthcare #medicaid (Source: Reuters: Health)
Source: Reuters: Health - September 3, 2023 Category: Consumer Health News Source Type: news
Big Pharma ’s American Con
In response to this week’s launch of a new program letting Medicare negotiate lower prices for a handful of medicines, drugmakers are insisting the initiative will limit patients’ access to medicine and stifle the development of new cures. However, all 10 of the drugs up for negotiation are…#medicare #democrats #endpointsnews #merck #newjersey #phrma #astrazeneca #boehringeringelheim #bristolmyerssquibb #johnsonjohnson (Source: Reuters: Health)
Source: Reuters: Health - September 2, 2023 Category: Consumer Health News Source Type: news
The Petri Dish: Boston Scientific device succeeds in trial, Sanofi vet joins Flagship
Cambridge venture firm Flagship Pioneering hired David Khougazian away from Sanofi ADR (Nasdaq: SNY) this week, bringing him on as a new growth partner. Khougazian had been with Sanofi since 2008, when he started as the general manager for the French pharmaceutical firm's Slovenian business. He was, for a time, chief of staff to Christopher Viehbacher while he was CEO, and from 2015 to 2017 served as CEO of Sanofi Pasteur MSD, a joint vaccine venture between Sanofi and Merck& Co. (NYSE: MRK). (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 31, 2023 Category: Biotechnology Authors: Rowan Walrath Source Type: news
US targets 10 drugs for pricing negotiations in crackdown on costs
Expensive medicines made by Pfizer, J&J and Merck selected for talks in biggest shake-up in decades (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - August 29, 2023 Category: Pharmaceuticals Source Type: news
Blockbusters From AbbVie, Merck, Lilly Highlight List Of 10 Drugs Subject To Price Cuts
Drugs from AbbVie, Bristol and Merck took slots on the list of drugs subject to price cuts. But the pharmaceutical stocks were unmoved. The post Blockbusters From AbbVie, Merck, Lilly Highlight List Of 10 Drugs Subject To Price Cuts appeared first on Investor's Business Daily.#abbvie #bristol #merck (Source: Reuters: Health)
Source: Reuters: Health - August 29, 2023 Category: Consumer Health News Source Type: news
Merck wins EU approval for Keytruda combo in gastric cancer
(Source: Reuters: Health)
Source: Reuters: Health - August 29, 2023 Category: Consumer Health News Source Type: news
