Roche touts phase 2 Gazyva data in lupus patients with a potentially fatal kidney complication

fiercepharma | June 11, 2019

One brand-new FDA approval and one trial win for its blood cancer drug Gazyva added up to a double dose of good news for Roche Monday. The Swiss drugmaker snapped up a combo approval for lymphoma drug Polivy, then touted Gazyva trial results in a completely different field: lupus nephritis, a potentially fatal complication of the autoimmune disease systemic lupus erythematosus. In a phase 2 study, adding Gazyva to standard lupus nephritis treatment beat that standard of care alone alone at delivering complete renal responses at one year. The drug also hit key secondary goals. There are no drugs specifically approved to treat lupus nephritis. The standard of care used in the trial combined one of two immunosuppressant drugs approved for organ transplant patients—CellCept or Myfortic—with corticosteroids and placebo. Roche plans to present the full data at an upcoming meeting.

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Chugai Pharmaceutical's mission is to add exceptional value through the creation of innovative medical products and services for the benefit of the medical community and human health around the world. We undertake actions that give the highest priority to patients and consumers.

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RESEARCH

Pfizer, Moderna urge calm as they launch tests of vaccines against mutated COVID-19

Pfizer | December 29, 2020

After a changed, quick spreading variation of COVID-19 in the U.K. disturbed worldwide travel throughout the end of the week, an upsetting inquiry arose: Will the new antibodies from Pfizer and Moderna neutralize this startling new strain of the infection? Presently the two organizations, alongside Pfizer's COVID-19 accomplice BioNTech, are racing to quiet an apprehensive public. They're dispatching new investigations intended to demonstrate their mRNA-based shots will fight off the new Covid strain, while at the same time communicating certainty this new antibody innovation is ideal for ensuring against quickly changing infections. Pfizer and BioNTech have tried their antibody "for its capacity to kill various freak strains. Until now, we have discovered steady inclusion of the multitude of strains tried," they said in an assertion. The organizations are currently gathering information from individuals who have gotten the shot to decide how well they "might have the option to kill the new strain from the U.K.," Pfizer added. Moderna didn't promptly react to a solicitation for input yet said in an assertion gave to other news sources that it expects "that the Moderna immunization instigated insusceptibility would be defensive against the variations as of late portrayed in the U.K.," and that it "will play out extra tests in the coming a long time to affirm this desire." Pfizer brought up that when SARS-CoV-2, the infection that causes COVID-19, first arose a year prior, it was clear there was more than one strain of it, and that it was transforming as it spread. SARS-CoV-2 is a RNA infection, and all things considered, it has "astoundingly high [mutation] rates" on the grounds that the chemicals it utilizes for replication are "inclined to mistakes when making new infection duplicates," the organization said. "One reason Pfizer and BioNTech decided to use a mRNA stage is a direct result of the potential for the adaptability of the innovation in contrast with customary immunization advancements," including the capacity to change the RNA arrangement in the antibody, should a strain arise that is not covered by the current shot," Pfizer added.

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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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PHARMA TECH

Piramal Pharma Solutions Announces Sterile Fill/Finish Program Theratechnologies Inc

Piramal Pharma Solutions, Theratechnologies Inc. | January 25, 2021

Piramal Pharma Limited's Pharma Solutions business, a leading contract development and manufacturing organization (CDMO), today declared that it is giving Theratechnologies Inc. with GMP manufacturing of sterile fill/finish drug item to help their developmental item as it goes into a first-in-people clinical investigation. The clinical material is being created at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is perceived around the world for its skill in sterile fill/finish administrations. It will be utilized in a Phase I preliminary for TH1902, Theratechnologies' lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I preliminary plan incorporates a portion acceleration study to assess the security, pharmacokinetics, most extreme endured portion (MTD) and fundamental enemy of tumor movement of TH1902 managed once at regular intervals in patients with cutting edge strong tumors headstrong to accessible enemy of malignant growth treatments. According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients." About Piramal Pharma Solutions Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services like development and manufacture of highly potent APIs and antibody drug conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide. About Piramal Pharma Limited Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 14 global facilities and a global distribution network in over 100 countries. PPL includes an integrated contract development and manufacturing (CDMO) business, Complex hospital generics business, and India Consumer Products business, selling over-the-counter products in India. In addition, it has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group. About Theratechnologies Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

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