Table of Content

Hello everyone, pharma professionals and lovers. Here’s the third issue of your newsletter made with ❤ by Ali Saad Agency for Translation Services.

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Pharma Game Changers

Merck to buy Prometheus Biosciences for about $11 billion

Merck & Co has agreed to acquire Prometheus Biosciences, Inc. Biosciences for around $10.8 billion to strengthen its presence in immunology. Merck will pay $200 per share for the biotech firm specializing in immunological disease treatment products, representing a 75% premium to Prometheus’ closing price on Friday. The acquisition will help Merck diversify its portfolio and protect itself from eventual revenue loss as patents on its cancer immunotherapy Keytruda expire towards the end of the decade. The deal is expected to close in Q3 2021. Source

Sterling Pharma Solutions granted MIA license for cGMP antibody-drug conjugate manufacturing at a UK facility.

Sterling Pharma Solutions has been granted a license to manufacture antibody-drug conjugates (ADCs) for clinical use at its cGMP-compliant manufacturing facility in Deeside, UK. The company acquired ADC Biotechnology in 2021, which led to the development of bioconjugation and ADC manufacturing capabilities at the Deeside site. The license allows GMP bulk drug substance manufacture to support clinical and stability studies. The Deeside facility will work parallel with Sterling’s facility in Germantown, Wisconsin. Sterling’s CEO, Kevin Cook, sees the granting of the license as a significant milestone for the company and plans to continue investment at Deeside as demand for these services increases. The Deeside facility will host an open day on May 16, 2023. Source

Eli Lilly Unloads Emergency Nasal Spray Diabetes Drug for $500M Up Front

Eli Lilly and Company is selling its emergency diabetes treatment, Baqsimi, to Amphastar Pharmaceuticals for $500 million upfront, with additional milestone payments of up to $450 million. Baqsimi is a powder formulation of glucagon used to treat severe hypoglycemia and was the first intranasal treatment for the condition to gain FDA approval in 2019. Amphastar already sells a generic version of injectable glucagon for emergency kits and is optimistic about Baqsimi’s growth potential. Lilly will focus on its pipeline of next-generation treatments for diabetes, including tirzepatide, which offers a dual mechanism for controlling blood sugar and has blockbuster potential. Source

Roquette opens a $25m US oral dosage innovation center.

Roquette has opened a $25m pharmaceutical innovation center in the US, which will act as a training and collaboration hub for pharmaceutical and nutraceutical manufacturers. The facility, located in the Northeastern pharmaceutical corridor near Philadelphia, will offer expert training, troubleshooting, and scale-up advice, as well as workshops and seminars on improving wet/dry granulation processes and strategies for continuous manufacturing. The center will also feature pharmaceutical processing, testing, and manufacturing equipment, including a range of simulators and analysis capabilities. Source

Japan’s Astellas to buy U.S. drugmaker Iveric Bio for $5.9 bil.

Astellas Pharma, a Japanese drugmaker, is set to acquire US pharmaceutical company Iveric Bio for $5.9 billion. Iveric Bio is seeking approval for a drug to treat age-related macular degeneration, which will join Astellas’s product portfolio alongside Padcev and fezolinetant. The purchase is part of Astellas’s strategy to boost its drug development through mergers and acquisitions and is expected to be completed by the end of September. Source

Cytiva and Pall Life Sciences complete integration: ‘Uniting gives us the focus, expertise, and talent to help our customers discover, develop and deliver the next generations of novel therapeutics.’

Cytiva and Pall Corporation‘s life sciences business have merged to create a bioprocessing portfolio covering lab-to-production scale with cell culture, single-use tech, chromatography, and filtration. With almost 16,000 associates in 40 countries, the company aims to promote digital solutions such as in-silico process development and predictive batch, with projected high single-digit core revenue growth and ongoing acquisition evaluation. Source

Pharma Law

FDA Requests Information on Food Labeling in Grocery E-Commerce

The FDA has issued a Request for Information to gather feedback from stakeholders about the content, accuracy, and format of food labeling information provided through online grocery shopping platforms. The agency seeks input to improve consumer access to consistent and accurate labeling information for online packaged foods. Interested parties can submit written or electronic comments within 90 days of publication in the Federal Register. Source

PhaMed Clinical Trials

Moderna & Merck plan Phase 3 trial for cancer vaccine with Keytruda

Moderna and Merck have released further data from the Phase 2b KEYNOTE-942 trial, which showed a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) for patients receiving personalized cancer vaccine mRNA-4157 in combination with Keytruda compared to Keytruda alone. The trial included patients with resected high-risk melanoma (stage III/IV), and a Phase 3 study is expected to commence this year. The companies also plan to expand development to additional tumor types, including non-small cell lung cancer. The released data supports the potential of mRNA-4157 in combination with Keytruda to help fight melanoma earlier and warrants investigation in a larger Phase 3 trial. Source

Tirzepatide Scores Win in Second Obesity Trial, SURMOUNT-2

Eli Lilly and Company‘s drug Tirzepatide has successfully met primary and key secondary endpoints in a clinical trial as an anti-obesity agent. It is a dual GLP-1 and GIP agonist approved for treating type 2 diabetes in adults. The trial enrolled 938 adults with overweight or obesity and type 2 diabetes and showed an average weight loss of 13.4%-15.7% from baseline with tirzepatide, compared to 3.3% with placebo. This success paves the way for FDA approval as an obesity treatment, which could be significant as previous GLP-1 receptor agonists have been popular among celebrities for weight loss. Source

Sanofi bets $750M to enter glycogen-lined Maze deal with lead asset waiting in the middle.

Sanofi licenses Maze Therapeutics‘ GYS1 program, including a lead asset for Pompe disease. Sanofi pays $150M upfront and up to $600M in milestones. Sanofi launches phase 2 trial and receives IP and know-how for GYS1 backup programs. Sanofi to decide on expanding MZE001’s use. Source

PhaMed Research

Head-to-Head Comparison of 25 Migraine Meds Reveals Top Options

Real-world data analysis on over 3 million migraine attacks has shown that triptans, ergots, and antiemetics are the most effective medications for relieving migraine headaches. The study, presented at the American Academy of Neurology (AAN) 2023 Annual Meeting, analyzed self-reported migraine attack records from a smartphone app called Migraine Buddy and analyzed 25 acute medications among seven classes. The study found that triptans, ergots, and antiemetics had the highest efficacy, followed by opioids, NSAIDs, combination analgesics, others, and acetaminophen. The study suggests that based on patient-reported outcomes, this comparative effectiveness analysis supports triptans and complements treatment recommendations from national headache societies based on randomized controlled trials and meta-analyses. Source

Brain Volume May Serve as Biomarker of Brain Injury in Patients With Sickle Cell Disease

According to a recent study, reduced gray and white matter volume in the brain are linked to anemia and reduced arterial oxygen content in patients with sickle cell disease (SCD). Elevated cerebral blood flow and infarct burden were also linked to reduced volume in subcortical structures among patients. The study highlights that silent cerebral infarcts represent just a portion of brain injury in patients with SCD, and brain volume can serve as another potential biomarker of brain injury in those with the disease. The measured brain volume deficits were subtle, and brain volume measurements at a single time point should be treated cautiously. Source

FDA Novel Drugs/Medical Device Approvals and Recalls

✔ The novel drugs approvals:

Qalsody (tofersen) Injection

Company: Biogen

Date of Approval: April 25, 2023

Treatment for: Amyotrophic Lateral Sclerosis

Qalsody (tofersen) is an antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

❌The FDA recalls:

1) Pro Power Knight Plus, NUX, Dynamite Super

Company: Gadget Island, Inc

Date of Recall: 04/26/2023

Product Description: Male enhancement capsules

Recall Reason: The product contains undeclared tadalafil and sildenafil

2) Numerous Brands

Company: Akorn Operating Company LLC

Date of Recall: 04/26/2023

Product Description: Various human and animal drug products

Recall Reason: As a result of bankruptcy, the firm is removing several products from the market due to the discontinuation of the Quality program, which would result in the company’s inability to assure that products meet the identity, strength, quality, and purity cha.

3) Mayne Pharma Inc.

Company: Teva Pharmaceuticals USA

Date of Recall: 04/28/2023

Product Description: FENTANYL Buccal Tablets CII

Recall Reason: Safety updates were omitted in the Product Insert/Medication Guide (MG)

That’s all for this issue. If you’re a new subscriber, look at the previous issues 1 and 2.