AbbVie, Amgen and Takeda Take Collaborative Efforts to Tackle COVID-19

Fiercepharma | August 03, 2020

The drug industry has come together in unprecedented collaborative efforts to tackle COVID-19. Now, as part of an R&D alliance, three big drugmakers are running a joint clinical trial to see whether their products can improve outcomes for severely ill patients. A recently launched clinical program, dubbed I-SPY, will test Amgen’s psoriasis med Otezla, Takeda’s hereditary angioedema therapy Firazyr and AbbVie’s experimental nonalcoholic steatohepatitis drug cenicriviroc to see if they can tamp down potentially life-threatening immune overreaction seen in some serious COVID-19 patients, the three companies said Monday. The primary endpoint of the study is time for severe COVID-19 patients on high-flow oxygen support to improve at least 1 point on an 8-point World Health Organization ordinal COVID status scale for at least 48 hours.

Spotlight

Pharmaceutical quality affects every American. FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMPs. This paper discusses some facts that may be helpful in understanding how CGMPs establish the foundation for drug product quality.

Spotlight

Pharmaceutical quality affects every American. FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMPs. This paper discusses some facts that may be helpful in understanding how CGMPs establish the foundation for drug product quality.

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Jubilant Radiopharma and SOFIE Biosciences Ink Strategic Collaboration Agreement to Further Advance the Field of Molecular Imaging & Therapeutics

SOFIE Biosciences, Inc. | November 05, 2020

SOFIE Biosciences, Inc. ("SOFIE"), an established radiopharmaceutical supplier and worldwide radiopharmaceutical contract manufacturing organization, and Jubilant Radiopharma, a business division of Jubilant Pharma Limited, announced that both the organizations have entered into a strategic partnership. Under the terms of the partnership, Jubilant Pharma, via one of its wholly owned subsidiaries, with 25% of equity holding shall be a strategic partner to SOFIE, enabling SOFIE to continue to grow production capacity, advance its theranostic pipeline, and support novel PET diagnostic manufacturing and distribution within the U.S. "SOFIE is a beacon of innovation, and with Jubilant's deep experience, uncompromised quality and customer-centric operations, we will bring game-changing theranostic solutions to nuclear medicine," stated Sergio Calvo, President of Jubilant's Radiopharmaceuticals Division. "With this new relationship, SOFIE achieves another milestone in our innovation strategy," Philipp Czernin, SOFIE's Chief Revenue Officer, remarked. "By engaging a well-established industry partner such as Jubilant Radiopharma, SOFIE will leverage the combined market presence and astute organizational structure to deliver breakthrough compounds to the nuclear medicine community. With respective distribution capabilities and the highly complementary product portfolio of SPECT and PET radiopharmaceuticals, both companies are well poised to create a single-vendor opportunity in select geographies." As part of the agreement, Jubilant Radiopharma will invest US $25m into SOFIE Biosciences. This funding will help accelerate the readiness timelines for SOFIE's state-of-the-art Theranostics Center of Excellence Manufacturing Facility in Totowa, New Jersey, as well as advance the development of their Fibroblast Activation Protein Inhibitor (FAPI) program. Patrick Phelps, SOFIE's President and Chief Executive Officer stated, "Under this strategic partnership, SOFIE is excited to meet the growing need to manufacture highly specialized radiopharmaceuticals, as well as become the first theranostic production center for FAPI in the US. FAPI has received worldwide acclaim for its value as a key next-generation theranostic agent with the ability to greatly enhance the detection and treatment of a wide variety of oncology diseases, and we believe with Jubilant Radiopharma's investment and support, we can accelerate the development and commercialization of this exciting family of compounds." "This agreement is yet another demonstration of Jubilant Radiopharma's long term commitment to the global Nuclear Medicine community. Our teams are dedicated to bringing to market the next generation of breakthrough products and industry-leading services to healthcare providers across the globe as part of our mission of improving lives through Nuclear Medicine," stated Pramod Yadav, CEO Jubilant Pharma Limited. About SOFIE Biosciences, Inc SOFIE's vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (Theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value Theranostic intellectual property, SOFIE is poised to deliver on the promise of nuclear medicine.

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PHARMA TECH

PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19

Pfizer | November 10, 2020

Pfizer Inc.and BioNTech SE today reported their mRNA-based antibody up-and-comer, BNT162b2, against SARS-CoV-2 has exhibited proof of adequacy against COVID-19 in members without earlier proof of SARS-CoV-2 contamination, in view of the principal break viability examination led on November 8, 2020 by an outer, free Data Monitoring Committee (DMC) from the Phase 3 clinical investigation. After conversation with the FDA, the organizations as of late chosen to drop the 32-case between time examination and lead the primary interval investigation at least 62 cases. Upon the finish of those conversations, the evaluable case check arrived at 94 and the DMC played out its first examination on all cases. The case split between inoculated people and the individuals who got the fake treatment shows an immunization viability rate above 90%, at seven days after the subsequent portion. This implies that insurance is accomplished 28 days after the inception of the immunization, which comprises of a 2-portion plan. As the investigation proceeds, the last antibody adequacy rate may shift. The DMC has not detailed any genuine security concerns and prescribes that the examination keeps on gathering extra wellbeing and viability information as arranged. The information will be talked about with administrative specialists around the world. “Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.” “I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.” “The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech Co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.” The Phase 3 clinical preliminary of BNT162b2 started on July 27 and has selected 43,538 members to date, 38,955 of whom have gotten a second portion of the immunization competitor as of November 8, 2020. Roughly 42% of worldwide members and 30% of U.S. members have racially and ethnically assorted foundations. The preliminary is proceeding to select and is relied upon to proceed through the last examination when an aggregate of 164 affirmed COVID-19 cases have gathered. The investigation likewise will assess the potential for the antibody possibility to give insurance against COVID-19 in the individuals who have had earlier presentation to SARS-CoV-2, just as immunization avoidance against serious COVID-19 infection. Notwithstanding the essential adequacy endpoints assessing affirmed COVID-19 cases accumulating from seven days after the subsequent portion, the last investigation currently will incorporate, with the endorsement of the FDA, new auxiliary endpoints assessing viability dependent on cases building 14 days after the subsequent portion also. The organizations accept that the expansion of these optional endpoints will help adjust information over all COVID-19 antibody reads and consider cross-preliminary learnings and correlations between these novel immunization stages. Pfizer and BioNTech are proceeding to gather security information and presently gauge that a middle of two months of wellbeing information following the second (and last) portion of the antibody up-and-comer – the measure of security information indicated by the FDA in its direction for likely Emergency Use Authorization – will be accessible by the third seven day stretch of November. Moreover, members will keep on being checked for long haul assurance and wellbeing for an extra two years after their subsequent portion. Alongside the viability information created from the clinical preliminary, Pfizer and BioNTech are attempting to set up the important wellbeing and assembling information to submit to the FDA to exhibit the security and nature of the antibody item delivered. In view of gracefully projections, we hope to flexibly internationally up to 50 million antibody portions in 2020 and fabricate up to 1.3 billion dosages in 2021. Pfizer and BioNTech plan to submit information from the full Phase 3 preliminary for logical friend survey distribution. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. About BioNTech Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

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InDex Pharmaceuticals to present the successful results of the CONDUCT study at two leading medical conferences

Prnewswire | August 24, 2020

We are very pleased that the abstract with the CONDUCT study results has been selected for oral presentation at both the UEGW and the ACG Annual Scientific Meeting", says Peter Zerhouni, CEO of InDex Pharmaceuticals. "These events are great opportunities for us to further reach the international scientific community with the successful results." UEGW is the largest scientific meeting for gastroenterologists in Europe and is this year held virtually October 11-13. The CONDUCT study will be presented on October 12 during the session "IBD: Clinical trials III" which starts at 16:30 CET. The abstract (OP117) is titled "COBITOLIMOD FOR MODERATE-TO-SEVERE LEFT-SIDED ULCERATIVE COLITIS (CONDUCT): A PHASE IIB, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING TRIAL".

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