UCR scientists are researching whether a plant-based messenger RNA vaccine can be created and aim to eliminate the need for the refrigeration of mRNA vaccines during transport and storage.
People with ulcerative colitis who are taking statins were found to have a 50% decreased risk of colectomies and hospitalization, according to a Stanford Medicine study.
Pfizer has expanded its voluntary recall to include all lots of varenicline (Chantix), but FDA allows continued distribution of the drug product to continue due to drug shortages.
Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.
FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.
Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.
Democrats failed to gain sufficient support to advance long-debated legislation to permit Medicare drug price negotiations.
The new FDA office will reorganize IT, data, and cybersecurity functions to an agency level.
Takeda’s Exkivity (mobocertinib) was approved by FDA for the treatment of patients with lung cancer.
BMG Pharma has signed an agreement with HTL for the development and commercialization of injectable products with sodium hyaluronate lipoate formate.
Apellis Pharmaceuticals has announced the top-line results from two Phase III studies, evaluating intravitreal pegcetacoplan as a treatment for geographic atrophy.
Symbiosis Pharmaceutical Services has successfully completed an on-site inspection, performed by the MHRA, of its expanded facility in Stirling, UK.
SGS has selected the European Centre for Clinical Research Training (ECCRT) for the provision of good manufacturing practice (GMP) training of its pharmacy team.
Exscientia has entered into a four-year agreement with the Bill & Melinda Gates Foundation for the development of small-molecule therapeutics that can tackle coronavirus and other viruses with pandemic potential.
GeneQuine Biotherapeutics has chosen Exothera to advance the development of its osteoarthritis gene therapy product candidate, GQ-303.
This paper explores the most important data challenges experienced by the rapidly modernizing pharmaceutical industry and proposes a GxP-compliant, ready-made application as a solution designed to increase efficiency in upstream processes, while maintaining data integrity and compliance.
The Syntegon AIM 5 utilizes an AI vision system for the inspection of syringe flanges, stoppers, and cylinders.
Emergent BioSolutions provides end-to-end service for all your drug substance and product development and manufacturing needs.
The joint venture with OSTHUS will expand PharmaLex’s IT consulting and system integration expertise.
CPC’s MicroCNX Series Connectors provide an alternative to tube welding at small tubing sizes.
AzurRx’s acquisition of First Wave Bio grants them access to their proprietary niclosamide formulations.
FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.
Thursday, September 16, 2021 at 10am EDT| 7am PDT| 3pm BST| 4pm CEST Choosing the right sterilization technique for your drug product and its packaging is not always a simple decision. Join the webcast on September 15th to learn about standard sterilization processes, be introduced to newer techniques, and understand how these techniques have been …
Shots: The approval is based on the P-I/II trial evaluating Exkivity (160 mg) in 114 patients with EGFR Exon20 insertion+ NSCLC who received prior Pt-based therapy The results demonstrated ORR (28%) as assessed by IRC & 35% as per investigator, m-DoR (17.5mos.), m-OS (24mos.), and m-PFS (7.3mos.) as per IRC Exkivity is a TKI inhibitor …
Wednesday, September 15, 2021 at 10am EDTDrug manufacturing demands and increased regulatory oversight are prompting pharmaceutical manufacturers to consider new processes for oral solid dose and aseptically processed drugs. A cross-section of industry experts will offer insight on emerging trends, technologies, and processes in this Technology Forum.
Shots: The approval is based on 2 trials i.e., P-II MAGNOLIA & P-I/II BGB-3111-AU-003 trial evaluate Brukinsa (160mg, bid or 320 mg, qd) in 66 & 20 patients with R/R MZL who received at least 1 anti-CD20-based regimen Both trial demonstrated ORR (56% & 80%), CR rate (20% & 20%) based on assessment using CT …
There are expectations that changes to pharma regulations in the EU, forming part of the regions broader strategy for the industry, will be positive and should offer flexibility for industry to advance through innovation.
Repligen and Navigo’s novel ligand could be the first to address antibody aggregation in low pH elution buffers.
AGC Biologics is expanding manufacturing capacity at its Heidelberg, Germany, facility for plasmid DNA and messenger RNA.
HUTCHMED’s amdizalisib (HMPL-689) received breakthrough therapy designation for the treatment of a subtype of non-Hodgkin’s lymphoma.
Both Marion Gruber and Phillip Krause, FDA officials, co-authored a document disputing the need for COVID-19 boosters for most people.
The memorandum of understanding between ABITEC and Luca AICell will work to advance ultra-high purity lipidic chemistries.
Boehringer Ingelheim and Twist Bioscience will use Twist’s antibody libraries to discover therapeutic antibody candidates.
When designing and manufacturing a pMDI or DPI combination drug-delivery device, the commercial stage should be kept in mind from the beginning of development.
Shots: The BLA submission is based on a P-III RATIONALE 302 trial evaluating the efficacy and safety of tislelizumab vs CT in 1972 patients with advanced or metastatic ESCC who had received prior systemic therapy. The anticipated PDUFA date for the therapy is July 12, 2022 The trial met its 1EPs i.e., the therapy showed …
Janssen’s Invega Hayfera is the first six-month injectable schizophrenia treatment approved by FDA.
Vector Laboratories has completed a $124 million cash buyout backed by Thompson Street Capital Partners and will begin an acquisition strategy to expand protein detection capabilities.
ABPI has announced that eight leaders from the patient and health charity sector have been chosen to join its new Patient Advisory Council.
ILC Therapeutics, has successfully closed a £3.5 million (US$4.9 million) pre-initial public offering (IPO) funding round.
NICE has reconsidered its decision on Janssen’s Erleada (apalutamide), issuing two positive final appraisal determinations (FADs) on the therapy.
NICE has recommended tofacitinib (Xeljanz, Pfizer)as an option for treating active polyarticular juvenile arthritis and juvenile psoriatic arthritis.
Sterling Pharma Solutions has invested in a center of excellence for research into commercial applications of continuous flow chemistry at its site in Dudley, UK.
Nanoform and Herantis Pharma’s proof of concept project evaluating the application of the nanoforming process has been successful.
Avantor has acquired the Masterflex bioprocessing business and related assets of Antylia Scientific.
The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.
Shots: Twist to receive an up front for each program and $710M in clinical, regulatory, and commercial milestones for the multiple target discovery programs Boehringer Ingelheim obtains global exclusive rights to develop and commercialize any therapeutic Ab discovered under the collaboration The collaboration will utilize Twist’s Ab libraries that derived from human sequences to discover …
Shots: The designation is based on the P-III EMPEROR-Preserved trial evaluates the safety and efficacy of empagliflozin (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes The results demonstrated a 21% reduction in risk for the composite 1EPs of CV death or hospitalization for adults with HF. The results were presented at …
Shares in Biogen have come under pressure after chief executive Michel Vounatsos admitted that the company is facing a much slower than anticipated rollout of its controversial Alzheimer’s disease therapy Aduhelm. Speaking at a Morgan Stanley conference yesterday, Vounatsos said Biogen may have to revisit its sales forecasts for Aduhelm (aducanumab), which were already “very …
Ask these five questions to find a smart CDMO partner for your projects. Probe strategically to experience fewer manufacturing issues, faster approval, and higher ROI.
Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.
Ardena acquires Idifarma, adding spray drying technology and high potency capabilities.
AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the advance purchase agreement for the delivery of Vaxzevria.
The Coalition for Epidemic Preparedness Innovations stated that developing the next generation of COVID-19 vaccines will only be possible if comparator vaccines are available for clinical trials.
FDA placed a clinical hold on the BMN 307 Phearless Phase I/II study, which was evaluating an investigational PAH gene therapy in adults with PKU.
Thermo Fisher Scientific plans to expand its Nashville, Tenn., site by establishing a dedicated single-use technology manufacturing facility at the site, doubling capacity.
Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.
Wednesday, September 8, 2021 at 8am EDT| 5am PDT| 1pm BST| 2pm CEST AI has opened up an enormous amount of possibilities for biomedical and life sciences organizations to use growing volumes of data to accelerate and improve upon critical processes that can speed time to value and improve patient outcomes. Learn how next generation …
Shimadzu’s LCMS-9030 is designed to deliver high-resolution, accurate mass detection with incredibly fast data acquisition rates, allowing scientists to identify and quantify more compounds with greater confidence.
The Novel Excipient Review Pilot Program will allow excipient manufacturers to obtain FDA review of certain novel excipients prior to use in drug formulations.
Orphan drug designation for Polaryx’s PLX-200 will facilitate research into its use treating Krabbe Disease, a rare lysosomal genetic disorder.
Shots: The approval is based on the P-III STOP 301 trial evaluates Trudhesa (0.725 mg/spray) in 5650+ patients with migraine with or without aura for 24 or 52 wks. The exploratory efficacy results showed that nasal spray provides rapid, sustained, and consistent symptom relief. The therapy is well-tolerated & no serious TEAEs were observed Trudhesa …
The potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.
Stakeholders work to meet deadlines, maximize benefits, and close gaps.
Element’s acquisition of Impact Analytical expands their life sciences footprint in North America.
A report from the bipartisan Congressional Budget Office analyzes how drug pricing policies could reduce the number of new therapies coming to market.
Immutep was granted a Chinese patent for LAG525, a LAG-3 antagonist antibody, under evaluation for cancer treatment.
Febles will oversee day-to-day aseptic manufacturing at Pharmaceutics International, Inc.
Thursday, September 2, 2021 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST
Shots: The approval is based on a P-III study that evaluates Invega hafyera (q6mos., twice-yearly injectable) vs Invega trinza in 702 adults in a ratio (2:1) aged 18-70yrs. with schizophrenia from 20 countries The results showed non-inferiority on 1EPs of time to 1st relapse @12mos. in ITT & per-protocol analysis sets., patients were relapse-free (92.5% …
The Eppendorf Pipette Software Update Tool provides free software updates for electronic pipettes or multi-dispensers.
The ROSS Double Planetary Mixer provides high-precision mixing, granulation, and vacuum drying.
The TP R Optima features a flexible arm design and individually controlled air exhaust flaps.
The Versynta FFP provides a flexible filling solution for liquid pharmaceuticals.
Shots: The approval is based on P-III ASPEN trial evaluating Brukinsa (160mg, bid, or 320 mg, qd) vs ibrutinib in 201 patients with WM who harbor an MYD88 mutation The 1EPs of the trial was VGPR rate in the overall ITT population as assessed by IRC. VGPR rate (28% vs 19%) based on the modified …
FDA will now require new and updated warnings about the increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions.
SK and GSK announce the initiation of a Phase III clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant.
Merck and Ridgeback Biotherapeutics announced the initiation of the Phase III clinical trial to evaluate an investigational oral antiviral therapeutic for the prevention of COVID-19 infection.
Two of FDA’s vaccine regulators will be leaving in the fall of 2021, which has the potential to impact COVID-19 vaccine recommendations for both children under the age of 12 and booster shots.
The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.
SpringWorks Therapeutics and the Dana-Farber Cancer Institute will conduct further research into the therapeutic potential of combination therapy with nirogacestat and anti-BCMA agents for multiple myeloma.
Aadi Bioscience has closed its previously announced merger with Aerpio Pharmaceuticals and a concurrent $155-million PIPE investment.
Quotient Sciences is investing £6.3 million ($8.68 million) into their drug substance manufacturing capabilities.
Avantor plans to address rising global demand for biologics with their investment in hydration capabilities.
Catalent’s acquisition of Bettera paves the way for growth in the softgel and oral dose formulation and manufacturing market for nutraceuticals.
USAntibiotics will serve as the sole American-based provider of amoxicillin and amoxil clavulanate.
Tuesday August 31, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CESTEfficiency for validation, changes to traditional practices to be more efficient and effective .
FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.
It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.
The pH effect encountered with oral oncology medication can be overcome with amorphous solid dispersions.
After receiving the COVID-19 vaccine from a batch of Moderna vaccines that were suspected to have contaminants, two people in Japan died. Meanwhile, another one million doses have been temporarily suspended in Japan.
Shots: Bio-Thera to receive $20M up front and $130M as development and commercial milestones and will be responsible for the development, manufacturing, and supply of BAT2206 Hikma get exclusive rights to commercialize the biosimilar in the US and received first-right-to-negotiate to add Europe (excluding CIS countries) BAT2206 is a mAb, that is a proposed biosimilar …
Shots: The approval is based on a study of 108 patients in the US and the UK, that showed patients treated with the Vivistim system had improved mobility than patients in the control group The device used in conjunction with rehabilitation therapy to improve motor function in the hands & arms following ischemic stroke. The …
The IPEC Foundation announced its 2021 award winners, who will be honored at their annual award ceremony in Philadelphia.
Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.
FSD Pharma has entered a definitive agreement to acquire all of the issued and outstanding shares of Lucid Psycheceuticals for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock.
FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).
FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.
Shots: The approval is based on the P-III heiGHt trial evaluating Skytrofa (qw) vs somatropin in 161 treatment-naïve children ≥aged 1yrs. with GHD who have growth failure due to inadequate secretion of endogenous GH The study met its 1EPs i.e., non-inferiority in AHV & showed a higher AHV @52wks., no serious AEs or discontinuations related …
The European Commission has approved UCB’s treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab).
Insilico Biotechnology has joined the Inno4vac project—an innovative European public-private partnership aimed at accelerating vaccine R&D timelines.
The University of Southern California and Amgen have teamed up to provide researchers access to two of Thermo Fisher Scientific’s cryo-EM instruments.
A new membrane staining kit, ExoBrite, launched by Biotium aims to enhance the detection of exosomes through flow cytometry.
Eli Lilly and Company and industry partners, including Ziath, are focused on speeding up the drug discovery process with a fully automated lab.
BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.
BioAgilytix, a US-based contract research laboratory focused on large-molecule drug development, has agreed to purchase 360biolabs, an Australia-based contract research organization specializing in virology and immunology.
Promega will demonstrate applications of bioluminescence tools at Discover Glo 2021.
Signal Rx Pharmaceuticals, Crystec, and ADYA Consulting are collaborating on the development of an inhaled dry powder formulation of SF2523 to treat pulmonary fibrosis, lung cancer, and SARS-CoV-2 related illnesses.
Aptamer Group and Bio-Works Technologies are partnering up to develop a new affinity resin for improved purification and scale-up of gene therapy vectors.
Thursday, August 26, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST This webcast will explore the benchmark practices for rapid progression from first-in-human to large-scale commercial manufacture for microdosing API. Micro-dosing at a commercial scale made effortless.
MHRA has approved Scancell’s clinical trial application for the initiation of the first-in-human Phase I/II study of Modi-1—a therapeutic vaccine candidate from the company’s Moditope platform.
CC Bio has raised £890,000 (US $1.2 million) in seed funding from CMS Ventures to accelerate the development of an innovative approach to infection treatment and prevention.
Shots: The FDA has approved the Oncomine Dx target test as a CDx to identify patients with IDH1 mutated CCA who may be candidates for Servier’s Tibsovo Oncomine Dx Target Test is NGS based CDx test that provides robust results in the IDH1 gene clinically associated with CCA & is currently approved in 15+ countries, …
AGC Biologics has broken ground on a new multipurpose facility in Copenhagen, Denmark, that will increase capacity.
Todos Medical has completed validation of its cPass neutralizing antibody blood test to monitor COVID-19 immunity.
NGM Biopharmaceuticals has disclosed a fourth antibody drug candidate, NGM831, for development into an oncology therapeutic.
Pfizer’s proposed $2.26-billion acquisition of Trillium Therapeutics will add next-generation hematology-targeted immuno-therapeutics to its oncology pipeline.
Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.
FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.
FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.
HHS Public Health and a team of medical experts recommend that COVID-19 vaccine booster shots will soon be necessary.
FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.
Shots: The approval is based on the longer-term follow-up data from the P-III trial that showed high efficacy and favorable safety profile through 6mos. after the second dose The vaccine will now be marketed as Comirnaty and is fully approved for the prevention of COVID-19 in individuals aged ≥16 yrs. The companies also plan to …
Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.
Monday, August 23, 2021 at 2pm EDT | 1pm CDT | 11am PDT What do Plato, Roombas, and digital twins for pharma manufacturing have in common? Learn how digital twins, powered by artificial intellingence, can reproduce conditions happening in physical assets to identify and optimize manufacturing process variables, predict outcomes, and empower to bio/pharma companies …
MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.
Novartis’ Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.
ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.
EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.
The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.
FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.
Shots: The FDA has approved the Ventana MMR RxDx Panel test as a CDx to identify patients with dMMR advanced solid tumors, who may be eligible for Jemperli monothx., based on the results of the MMR biomarker test Ventana MMR RxDx Panel provides access to clinicians with fully automated panel of MMR biomarkers tested by …
3P Innovation has won a Princess Royal Training Award for its Graduate Development Programme (GDP).
UK’s ABPI responds to the latest revisions being made to NICE methods fpr assessment of drugs and devices.
Curia plans to expand the site’s commercial capabilities with this move.
Merck KGaA has partnered with Telix Pharmaceuticals to conduct combination clinical studies for cancer therapy.
Corning’s new Ascent fixed bed reactor (FBR) system is an automated bioproduction platform designed to significantly improve yields and reduce bioproduction costs.
The collaboration will focus on the interactions between WTX-124 indukine and KEYTRUDA (pembrolizumab).
A new method developed by the NIH bypasses genetic RNA extraction, simplifying the testing process.
Shots: The approval is based on the P-III EMPEROR-Reduced trial evaluating the effect of Jardiance (10 mg, qd) vs PBO in 3730 adults with HFrEF with/out T2D The results demonstrated a 25% reduction in the relative risk of the primary composite EPs of time to CV death or hospitalization for HF. The 2EPs demonstrated 30% …
FDA approves Merck’s Welireg for the treatment of adult patients with von Hippel-Lindau disease who require therapy for tumor growth.
WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.
BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.
Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.
Cipla receives final approval from FDA for its abbreviated new drug application for difluprednate ophthalmic emulsion 0.05%.
TriRx hosts various leaders at a ribbon-cutting ceremony for their new facility.
BlueAllele has been granted a US patent for its advanced gene-editing technology, PALIDON, which is compatible with existing gene editing nucleases and delivery systems.
The Cleveland, Ohio facility will produce critical anti-infective drug products for US hospitals.
Artiva Biotherapeutics’s new R&D and GMP manufacturing center in San Diego, Calif., for NK cell therapies is expected to open in 2022.
Shots: The NDA & MAA submissions are based on ongoing 2 studies i.e., ACTIVATE & ACTIVATE-T evaluates safety, tolerability & efficacy of mitapivat vs PBO in patients with PKD Results: 40% of patients achieved a hemoglobin response, 33% reduction in transfusion burden @ 24wks. fixed dose period & safety profile was consistent with previously reported …
Thermo Fisher’s manufacturing site in Greenville, NC was recognized for manufacturing excellence.
Syngene’s additions include a new microbial facility and an expanded mammalian facility.
Focus on the contribution of modified release technologies
Primates inoculated with CV2CoV show improved immune response and protection from various COVID variants.
FDA has granted its first approval for an idiopathic hypersomnia treatment.
Shots: The approval is based on P-III PRONTO-PUMP-2, a treat-to-target study that evaluates the efficacy & safety of Lyumjev (insulin lispro-aabc injection, 100 units/mL) vs Humalog (insulin lispro injection, 100 units/mL) in 432 adults in a ratio (1:1) with T1D for 16wks. The study met its 1EPs i.e., non-inferior A1C reduction from baseline @16wks. Lyumjev …
FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.
The Co-chairs of the 2021 PDA/FDA Joint Regulatory Conference Program Planning Committee share their insights about this important conference, now in its 30th year. They will discuss the importance of hitting this significant milestone, what noted regulatory and industry speakers will be presenting, what’s new this year, what popular sessions are making a return, and …
This tech note evaluates intra- and inter-system retention time and peak area precision for the analysis of two active pharmaceutical ingredients and their related impurities
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
Shots: The company has received the FDA’s CRL declining the approval of Vicineum’s BLA to treat BCG-unresponsive NMIBC The FDA has provided recommendations to conduct additional clinical/statistical data and analyses of roxadustat in addition to CMC issues related to a recent pre-approval inspection and product quality The company plans to meet with the FDA as …
Terumo Blood and Cell Technologies and PhotonPharma announced a collaboration to develop a novel tumor-specific immunotherapy for solid tumors.
PNI expands global headquarters with a new 75,000-square-foot facility, which will include multiple GMP suites for manufacturing RNA therapeutics and vaccines.
The companies announce the results of a research collaboration that applied machine learning to significantly advance the scalability of spirulina-based biologic drugs.
Eli Lilly and Company and Incyte have announced promising results that patients with COVID-19 on mechanical ventilation saw a reduction in deaths with the addition of baricitinib treatment.
Almac Sciences has signed a manufacturing agreement with Pila Pharma for the production of the API XEN-D0501.
Bayer has acquired Vividion Therapeutics, a US-based biopharmaceutical company.
Rentschler Biopharma has broken ground nearby its Milford, Mass., site where it will build its new multi-product manufacturing facility for commercial production of complex molecules.
Lykan Bioscience and Vineti will combine their capabilities to streamline process development and manufacturing to move cell therapies through clinical phases to commercialization.
The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.
The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.
Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.
Friday, August 13, 2021 at 11am EDT| 8am PDT| 4pm BST|5pm CEST
Consider tactics to meet sustainability objectives for temperature-controlled packaging.
Shots: The designation is based on the P-III JUPITER-02 trial evaluating toripalimab + CT vs CT alone in patients with NPC. The result was presented at ASCO 2021 The results demonstrated an improvement in PFS. The trial also meets 2EPs of PFS assessed by the investigator and ORR as assessed by BIRC including higher DoR; …
Shots: The approval is based on the P-III withdrawal study that evaluates the efficacy and safety of Xywav (twice or once-nightly regimen, oral solution) vs PBO in adults with IH. The therapy is expected to be available in late 2021, following REMS implementation The results demonstrated the change in the 1EPs of ESS score & …
Ask these five questions to find a smart CDMO partner for your projects. Probe strategically to experience fewer manufacturing issues, faster approval, and higher ROI.
A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.
FDA has awarded Fast Track designation to Vivet Therapeutics’ novel gene therapy, VTX-801.
A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.
Veraxa and Indivumed will work together to develop colorectal antibody drugs.
Lonza and Sheba Medical Center have successfully dosed four patients with a CD19 autologous CAR-T cell therapy using Lonza’s Cocoon automated manufacturing platform.
Moderna will build an mRN vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.
The Just – Evotec Biologics facility in Redmond, Wash., uses the company’s J.POD technology.
The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.
Nobelpharma has come to terms on an agreement to use ProBioGen’s vaccine manufacturing platform AGE1.CR.plX.
Shots: The US FDA has granted ODD to CFT7455 for the treatment of MM. The FDA grants ODD to drugs & biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the US In Jun’21, the company has initiated a …
Shots: The approval is based on P-III CLEAR /KEYNOTE-581 trial that evaluates Keytruda (200 mg, IV, q3w) + Lenvima (20 mg, PO, qd) or Lenvima (18mg) + everolimus (5mg, PO, qd) vs sunitinib (50 mg, q4w) in a ratio (1:1:1) in 1,069 patients with advanced RCC The results demonstrated an improvement in PFS with a …
The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.
Datwyler offers the StarterPack packaging system designed to aid in the development of parenteral drug packaging.
Shots: The company has received an FDA’s CRL declining the approval of roxadustat’s NDA to treat anemia of CKD The FDA has requested to conduct an additional clinical study of roxadustat before resubmission The therapy is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in both NDD and …
Shots: The US FDA has granted 510(k) clearance for EXALT Model B single-use Bronchoscope to use in bedside procedures within ICU and OR and will be available in the US in the coming wks. The device is being used for bronchoscopy procedures including secretion management, airway intubation, percutaneous tracheostomy, double-lumen endotracheal tube placement, and biopsies …
Shots: The application is based on ORR data from cohorts D & K of KEYNOTE-158 trial evaluating Keytruda as monothx. (200 mg, q3w) in 90 patients with MSI-H/dMMR advanced EC with disease progression following prior systemic therapy in any setting & are not candidates for curative surgery or radiation This indication is approved under accelerated …
Shots: The NDA is based on P-III PSOARING 1 & 2 along with interim results from PSOARING 3 OLE study evaluating the safety & efficacy of tapinarof vs vehicle in patients with PsO In PSOARING 1 & 2 results: patients achieved a PGA score of 0 or 1 (35.4% vs 6% & 40.2% vs 6.3%) …
The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.
After a disruptive year in the pharma industry, it’s time to adapt to the next normal. Learn about the four main trends shaping the evolving industry.
Shots: The sBLA is based on P-III KEYNOTE-564 trial evaluating Keytruda monothx. (200mg, IV on day 1 of each 3wks. cycle for ~17 cycles) vs PBO in 994 patients with RCC, following nephrectomy and resection of metastatic lesions The results demonstrated an improvement in DFS and were presented at ASCO 2021 with an anticipated PDUFA …
Kyowa Pharmaceutical Industry and Bora Pharmaceuticals have announced a partnership to produce generic-drug product for filing in Japan.
Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.
The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.
EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.
KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product.
FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.
AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.
The guidance aids in the development, validation, and use of near infrared-based analytical procedures.
Shots: The US FDA has granted FTD to selinexor (NOX inhibitor) for the treatment of PBC. Additionally, the therapy has previously received ODD for PBC in the US & EU The P-II clinical trial of the therapy demonstrated anti-fibrotic activity as measured by Fibroscan and showed favorable tolerability profile along with the impact on fatigue …
Syntec receives warning letter where FDA finds deviations from CGMP for APIs.
BeiGene plans to build a new campus for R&D and commercial-scale biopharmaceutical manufacturing in Hopewell, NJ.
Novavax and European Commission have finalized an agreement to purchase up to 200 million doses of a COVID-19 vaccine.
Metrics Contract Services announces the completion of a $10 million expansion to their Greenville, NC facilities.
Catalent finalizes their acquisition of iPSC developer and manufacturer RheinCell Therapeutics.
Syngene International appoints two US-based executives to senior level positions.
Artificial Intelligence (AI) is changing how biotech and pharmaceutical companies operate. Increased competition and an enhanced regulatory landscape are forcing drug manufacturers to eliminate waste, create efficiencies and squeeze every last bit of productivity out of existing processes. The benefits can be enormous. A three percent increase in usable yield could increase revenue by millions …
TriRx continues to expand its manufacturing capabilities with the acquisition of the Elanco Animal Health Facility in Shawnee, Kansas.
Thursday, August 5, 2021 at 11am EDT| 8am PDT| 4pm BST|5pm CEST
BMG Pharma’s clinical trial has demonstrated positive results in the efficacy of BMG0705 Nasal Spray and BMG0703A Mouth Rinse as treatments for asymptomatic COVID-19 patients.
Evonik has acquired the German biotech company JeNaCell, expanding its biomaterials portfolio.
Nanoform and Boehringer Ingelheim have executed a master services agreement in relation to pre-clinical development projects.
EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.
WuXi STA has finalized its acquisition of Bristol Myers Squibb’s drug product manufacturing facility based in Couvet, Switzerland.
Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment
EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.
Bioiberica has received certification of its CSR management system as aligned with the United Nations Sustainable Development Goals.
The University of Sheffield has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.
A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.
Sanofi has acquired Translate Bio in a bid to further their mRNA research.
CMA fines Advanz and investors for more than £100 million (approximately US$139 million) after the company increased the price of thyroid tablet packs from £20 (US$23.74) in 2009 to £248 (approximately US$295) in 2017.
FDA approved an expanded Botox label, which now includes eight new muscles to treat adults with upper limb spasticity.
Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.
BioMed X Institute and Janssen Research & Development to start two new research programs in the field of autoimmune diseases and drug delivery.
Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.
FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.
FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.
The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.
DisperSol and Catalent announce manufacturing collaboration to accelerate DisperSol’s pharmaceutical production.
FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.
In an interview with PharmaShots, Dr. Bassil I. Dahiyat, President and CEO of Xencor shared his views on the company’s collaborations with BMS and its Xtend XmAb technology. He also shed light on the EUA of Sotrovimab for COVID-19. Shots: The FDA has granted EUA to Vir and GSK’s sotrovimab, which was engineered with Xencor’s …
Shots: The application is based on the P-III IMpower010 study evaluating the efficacy & safety of Tecentriq vs BSC in 1005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant cisplatin-based CT The results from an interim analysis showed the reduction in the risk of …
Shots: Abbott launches its latest Jot Dx ICM with new features to help clinicians for a constant flow of heart rhythm data to treat atrial fibrillation Jot Dx ICM allows 24/7 heart monitoring and connects directly with Abbott’s myMerlin smartphone app. The technology is designed to provide remote detection and improved diagnostic accuracy of cardiac …
Dosage form priorities are shifting to focus on user-friendliness, leading to greater engagement with outsourcing partners earlier in development timelines.
Amorphous solid dispersions can overcome the pH effect encountered with oral oncology medications.
Data sharing facilitates traceability, transparency, and accuracy while driving efficiencies and boosting quality of active pharmaceutical ingredients.
Collaborative partnerships can foster success in formulation development projects.