Pharma's Almanac

GSK to Support Manufacture of Novavax’ COVID-19 Vaccine

Nice Insight — Thu, 01 Apr 2021 13:00:00 GMT

GSK to support manufacture of up to 60 million doses of Novavax’ COVID-19 vaccine
Manufacturing to take place at GSK UK facility at Barnard Castle

GSK has reached an agreement in principle with Novavax and the UK Government Vaccines Taskforce to support manufacturing of up to 60 million doses of Novavax’ COVID-19 vaccine candidate (NVX-CoV2373) for use in the UK. GSK will provide ‘fill and finish’ manufacturing capacity at its Barnard Castle facility in the North East of England beginning as early as May 2021, with a rapid technology transfer between the two companies beginning immediately. The parties will negotiate a final agreement to include additional terms and conditions.

Pyxis Oncology Closes $152 Million Series B Financing to Further Advance Portfolio of Biologics

Nice Insight — Thu, 01 Apr 2021 13:00:00 GMT

— New round enables Pyxis to advance differentiated antibody-drug conjugate (ADC) and immuno-oncology (I/O) programs to next value inflection point

— In addition to recently announced in-licensed ADC candidates and ADC toolkit from Pfizer, funding to support in-licensed ADC candidate from LegoChem Biosciences —

CAMBRIDGE, Mass. – Pyxis Oncology (“Pyxis” or the “Company”) today announced the closing of a $152 million Series B financing, led by Arix Bioscience and co-led by RTW Investments, LP, with participation from additional new investors, including Perceptive Advisors, RA Capital Management, Pfizer Ventures, BVF Partners, L.P., Janus Henderson Investors, Cormorant Asset Management, HBM Healthcare Investments, funds managed by Tekla Capital Management LLC, Acuta Capital Partners, Ridgeback Capital Investments, Surveyor Capital (a Citadel company), Laurion Capital Management, Logos Capital, and LifeSci Venture Partners. This round brings Pyxis’ total funding to $174 million. The Longwood Fund-founded Company’s existing Series A investors including Leaps by Bayer, Longwood Fund, Agent Capital and Ipsen also participated in the offering.

Piramal Pharma Ltd. To Acquire 100% Stake in Hemmo Pharmaceuticals, a Leading Indian Manufacturer of Peptide APIs

Nice Insight — Wed, 31 Mar 2021 13:00:00 GMT

- The acquisition will add peptide API development and manufacturing capabilities

- Peptide drugs are growing significantly in oncology and metabolic therapies

- Piramal’s integrated drug substance and drug product offering will now include peptides

BrainScope Launches Next-Gen Medical Device for Concussion Detection

Nice Insight — Tue, 30 Mar 2021 13:00:00 GMT

FDA-cleared Concussion Index is the only brain activity-based biomarker for rapid, objective baselining and assessment of concussion at injury and recovery time points

Bethesda, MD – BrainScope today announced the availability of its third groundbreaking FDA-cleared algorithm on the BrainScope device. The Concussion Index is the first physiological marker of concussive injury that aids clinicians in the objective assessment of patients at baseline, point of injury, and through recovery. The Concussion Index adds to the suite of FDA cleared algorithms already available on the BrainScope device and in clinical use today to rapidly triage suspected mild traumatic brain injuries, from brain bleeds to concussion. BrainScope has been demonstrated to have the potential to reduce the use of head CAT Scans by more than 30% when used by Emergency Departments in triage, sparing patients unnecessary brain radiation while also providing an important assessment of concussion. It fits easily into any clinical workflow as it is fast and portable.

Celonic and CureVac Announce Agreement to Manufacture over 100 Million Doses of CureVac’s COVID-19 Vaccine Candidate, CVnCoV

Nice Insight — Tue, 30 Mar 2021 13:00:00 GMT

Celonic is prepared to manufacture more than 100 million doses of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV, per year
More than 50 million doses are expected to be produced before the end of 2021
The mRNA-based vaccine will be manufactured at Celonic’s state-of-the-art facility in Heidelberg, Germany

TÜBINGEN, Germany/ BOSTON, USA/ BASEL, Switzerland -- CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA) and Celonic Group, a premium biopharmaceutical Contract Development and Manufacturing Organization (CDMO) specializing in the development and production of Advanced Therapy Medicinal Products (ATMPs) and mammalian cell line-expressed bio-therapeutics, today announced their partnership for the production of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV.

Blockchain: Increasing Efficiency and Transparency Across the Supply Chain

tj@thatsnice.com (KshitiJ (TJ) Ladage) — Mon, 29 Mar 2021 19:00:55 GMT

But First—What is Blockchain?

Blockchain is a ledger of decentralized data that is securely shared among a group of select participants.¹ While Bitcoin may be why people are at least vaguely familiar with blockchain’s existence, blockchain itself is not synonymous with cryptocurrency — rather, cryptocurrency is built on blockchain technology, but the technology also seemingly has endless potential for a wide range of applications in the pharmaceutical industry.

NeuroRx Announces ZYESAMI™ Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival from Critical COVID-19

Nice Insight — Mon, 29 Mar 2021 13:00:00 GMT

RADNOR, Pa. -- NeuroRx, Inc. today reports 60-day results of the Phase 2b/3 trial of intravenously-administered ZYESAMI™ (aviptadil acetate) for the treatment of respiratory failure in critically-ill patients with COVID-19, which is being developed in collaboration with Relief Therapeutics Holding AG (SIX:RLF,OTCQB:RLFTF). Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site.

Shorten Time to Market with New Data-Driven Lyophilization Process

Jeff Tremain — Mon, 29 Mar 2021 10:00:00 GMT

Lyophilization has become a necessary and effective component of drug product manufacturing across the pharmaceutical industry, driven by safety, quality, and stability. Lyophilization remains a complex process that poses particular challenges during tech transfer and scale-up, but newer, data-driven approaches offer more efficient routes to process optimization. The use of computational fluid dynamics (CFD) for modeling development, advanced analytics, and state-of-the-art GMP lyophilization equipment enables better understanding of the process and reduces the time required for optimization of robust, scalable lyophilization processes. Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and leading-edge data and analytical capabilities can reduce the drug development process and expedite time to market for lyophilized drugs.

Safety, Quality, and Stability Drive Lyophilization

Biologic pharmaceutical products, including traditional monoclonal antibodies and next-generation products, such as monoclonal antibodies, bispecific antibodies, and others, continue to advance through the clinic and are expected to account for a larger percentage of drug approvals in the future.

Exploring the Natural Pharmacopeia and Incubating a Biotech Company

Andrea Small-Howard, Ph.D. — Mon, 29 Mar 2021 09:30:00 GMT

Using high-throughput screening, computer modeling based on proprietary algorithms, and disease-specific cell and animal models, GB Sciences has rationally designed plant-inspired, optimized therapeutic mixtures containing synthetic homologues that are identical copies of plant-based substances. The company has several candidates soon to enter the clinic and is taking steps to ensure their success and further advance its proprietary discovery capabilities.

Plants as Effective Biochemists

When one examines the history of Western medicine, many of the drugs used throughout history — including today — were derived from plants. In fact, greater than 50% of all drugs that have been approved by the U.S. FDA were at least initially isolated from plant species.

GEA Introduces Single-Use Disc Stack Separator kytero® for Cell Harvesting at Achema Pulse

Nice Insight — Wed, 24 Mar 2021 16:35:00 GMT

A world leader in centrifuge technology, GEA, is now entering the single-use separator market. Preceded by a rigorous development and testing process, the result combines the outstanding performance of larger GEA stainless steel pharma centrifuges with the features and benefits that single-use separation provides. This type of equipment is in high demand among biopharmaceutical manufacturers worldwide.