FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer
On October 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-sm (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 16, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Approves Keytruda (pembrolizumab) for Treatment of Patients With Resectable NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Single Agent as Adjuvant Treatment After Surgery
RAHWAY, N.J.--(BUSINESS WIRE) October 16, 2023 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda , Merck’s anti-PD-1 therapy, for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 16, 2023 Category: Drugs & Pharmacology Source Type: news
Merck to open £1bn London research centre with plea for government support of industry
Drugmaker praises country’s scientific expertise but says it must address conflicts in areas such as drug pricing#drugmaker (Source: Reuters: Health)
Source: Reuters: Health - October 15, 2023 Category: Consumer Health News Source Type: news
Merck to open £1bn London research centre with plea for government support of industry
Drugmaker praises country’s scientific expertise but says it must address conflicts in areas such as drug pricing (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - October 15, 2023 Category: Pharmaceuticals Source Type: news
Merck's Keytruda combo gets EMA panel backing for expanded use in gastric cancer
(Source: Reuters: Health)
Source: Reuters: Health - October 13, 2023 Category: Consumer Health News Source Type: news
US Plans Shift of Merck COVID Treatment to Commercial Market US Plans Shift of Merck COVID Treatment to Commercial Market
The government will stop distributing free doses of Merck ' s COVID-19 antiviral treatment molnupiravir by the middle of next month and expects it to be sold on the commercial market instead.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 5, 2023 Category: Consumer Health News Tags: Infectious Diseases News Source Type: news
Sanofi pays Teva $500M to join red-hot bowel disease race
Sanofi is splashing the cash. | Sanofi is splashing the cash. One day after inking a $175 million vaccine deal, the French drugmaker has splurged another 469 million euros ($500 million) on a Teva program to secure the chance to challenge Merck & Co. and Roivant for an emerging inflammatory bowel…#teva #merckco (Source: Reuters: Health)
Source: Reuters: Health - October 4, 2023 Category: Consumer Health News Source Type: news
Pharma Giants Combine Forces to Fight New M & A Rules
Meet the anti-antitrust coalition. With a looming overhaul of US merger-and-acquisition law set to reshape the economics of the M&A-heavy pharmaceutical industry, 31 of its biggest players — including Merck, Amgen, Abbvie, and Gilead — formed an alliance to fight the reforms. Their chief enemy?…#merck #amgen #gilead #khantstopmenow #linakhan #ftc #departmentofjustice #horizontherapeutics #tepezza #krystexxa (Source: Reuters: Health)
Source: Reuters: Health - October 4, 2023 Category: Consumer Health News Source Type: news
Teva Pharma Hooks Sanofi In $1.5 Billion Inflammation Deal. But Shares Tumble
Teva stock yo-yoed and then tumbled Wednesday after the company announced it would partner with French pharma giant Sanofi (SNY) to develop an inflammatory bowel disease treatment. The drug belongs to the emerging TL1A class and could eventually rival experimental treatments from Roivant Sciences…#roivantsciences #pfe #merck #prometheusbio #teva #sanofi #tevapharmaceutical #crohn #prometheus #paulhudson (Source: Reuters: Health)
Source: Reuters: Health - October 4, 2023 Category: Consumer Health News Source Type: news
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
