Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) approval and first U.S. implants of the SenSight™ Directional Lead System used for Deep Brain Stimulation (DBS) therapy. SenSight is the first-of-its-kind DBS directional lead that combines the benefits of directionality with the power of sensing, allowing physicians to deliver precise, patient-specific DBS therapy for the treatment of some symptoms associated with movement disorders like Parkinson's disease, dystonia and essential tremor, and medically refractory epilepsy.
Monday, June 7, 2021
bluebird bio: FDA Lifts Clinical Hold for Sickle Cell Disease and β-Thalassemia Studies
bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical holds on the Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy (bb1111) for adult and pediatric patients with SCD, and the Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies of betibeglogene autotemcel gene therapy (beti-cel; licensed as ZYNTEGLO™ in the EU and the UK) for adult, adolescent and pediatric patients with transfusion-dependent β-thalassemia (TDT). The company is working closely with study investigators and clinical trial sites to resume all study activities as soon as possible.
"Patient safety continues to be our utmost priority, and we are grateful for the close partnership with the FDA, investigators, scientists and most importantly, patients, who all contributed to the assessments of the adverse events in HGB-206 that ultimately led to today’s announcement," said Andrew Obenshain, president, severe genetic diseases, bluebird bio. "As pioneers in gene therapy, we remain committed to advancing the field through our learnings. Over the past four months, we have gained deeper knowledge and understanding of the pathophysiology of sickle cell disease that will allow us to better serve patients and the broader community. We look forward to resuming our clinical programs and continuing to advance toward major regulatory submissions for sickle cell disease and β-thalassemia."
Previously Reported Safety Events
On March 10, 2021, bluebird bio reported that it is very unlikely the suspected unexpected serious adverse reaction (SUSAR) of acute myeloid leukemia (AML) reported in the HGB-206 study of LentiGlobin for SCD was related to the BB305 lentiviral vector (LVV). No cases of hematologic malignancy have been reported in any patient who has received treatment with beti-cel. On April 20, 2021, bluebird bio announced a revised diagnosis for the previously reported case of myelodysplastic syndrome (MDS) in its Phase 1/2 study of LentiGlobin for SCD. Upon further assessment, the treating investigator concluded this is not a case of MDS and revised the diagnosis to transfusion-dependent anemia.
One Medical Agrees to Acquire Iora Health
1Life Healthcare, Inc. (One Medical) (Nasdaq: ONEM), a leading human-centered and technology-powered primary care organization, today announced it has entered into a definitive agreement to acquire Iora Health, a human-centric, value-based primary care group with built-for-purpose technology focused on serving Medicare populations, in an all-stock transaction valued at approximately $2.1 billion.
“We are delighted to announce plans to combine with Iora Health, a technology-powered primary care leader delivering outstanding member-based, value-based care for adults 65+ enrolled in Medicare Advantage and other at-risk reimbursement models. Together we will expand our addressable market to serve more members in more geographies with digital and in-person care across every stage of life, with further capabilities to deliver care within full-risk models. Together with Iora Health, we can deliver better health, better care, and lower costs for children, adults, and seniors,” said Amir Dan Rubin, Chair & CEO of One Medical.
“Chris McKown and I founded Iora Health over 10 years ago to build an innovative primary care model that transforms lives and improves outcomes through relationship-based care, and we are excited to take this next exciting step with One Medical,” said Rushika Fernandopulle, M.D., MPP, Co-Founder and Chief Executive Officer of Iora Health. “Together, with our aligned cultures, shared mission, and complementary models, we can drive even greater impact for our patients, our teams, and our investors, and most importantly, our shared vision of transforming healthcare.”
One Medical and Iora Health are aligned in their missions, models, and cultures to transform healthcare for key stakeholders -- Consumers, Employers and Payers, Providers, and Health Networks. Together, the two companies can further accelerate and build upon their impacts for these stakeholders, while simultaneously expanding their models in existing markets, entering new markets, serving new populations, expanding full-risk models, and leveraging their purpose-built technologies for increased growth and scale.
Strategic and financial benefits of the transaction include:
- Creates a premier national member-based, technology-powered primary care platform to deliver better health, better care, and lower costs across Commercial and Medicare populations;
- Positions One Medical with Iora Health to advance the health of members across every stage of life;
- Extends One Medical’s platform to deliver multi-modal care with 24/7 national digital health and in-person care across a combined 28 markets and beyond;
- Expands potential market opportunity to $870 billion across Commercial and Medicare segments, including the new Medicare Direct Contracting program;
- Enhances One Medical’s risk-taking capabilities and extends One Medical into full-risk Medicare reimbursement models;
- Amplifies the power of purpose-built technologies to deliver premier member experiences, population health, provider support, and value-based care across every stage of life;
- Accelerates the expansion of two high-growth organizations, with complementary cultures and models serving as a premier place to practice modernized healthcare; and,
- Offers an opportunity to create significant value, with an expected $350+ million in annual revenue synergies by 2025, ~$30 million in annual net cost synergies by 2025, and with ~$30 million in cumulative capex savings through 2025.
“One Medical has proven its ability to drive profitable membership growth, engage with members, improve health outcomes and lower costs. I am excited at the prospect of creating even more differentiation by adding Iora Health’s Medicare-focused capabilities, expanding our reach to 28 markets, and offering our service experience to the parents and grandparents of our 598 thousand members,” said Bjorn Thaler, Chief Financial Officer, One Medical.
Leadership and Governance
A designee of Iora Health will join the One Medical Board and Rushika Fernandopulle will become One Medical’s Chief Innovation Officer.
Transaction Details
Under the terms of the agreement, Iora Health shareholders will receive 56.1 million shares of One Medical common stock. Based on the closing share price of One Medical’s common stock of $35.59 on June 4th, 2021, the total transaction is valued at approximately $2.1 billion. Upon completion of the transaction, Iora Health shareholders are expected to own approximately 26.75% of the combined company.
The transaction is expected to close in late Q3 or Q4 of 2021 and is subject to customary closing conditions, including approval by One Medical and Iora Health stockholders and receipt of regulatory approval.
Advisors
Morgan Stanley & Co. LLC served as exclusive financial advisor to One Medical and Cooley LLP served as legal advisor.
Credit Suisse served as exclusive financial advisor to Iora Health and Skadden, Arps, Slate, Meagher & Flom LLP served as legal advisor.
Conference Call Details
One Medical will host a conference call at 5:00 a.m. (PT) / 8:00 a.m. (ET) on Monday, June 7, 2021, to discuss this transaction. A live audio webcast and a supplemental presentation will be available online at https://investor.onemedical.com. The conference call can also be accessed by dialing 1-800-258-1651 for U.S. participants, or 1-612-979-9928 for international participants, and referencing conference ID 2077477. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call, at the same web link, and will remain available for approximately 90 days.
Amneal Files Dihydroergotamine (DHE) Autoinjector NDA for Migraines and Cluster Headaches
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") today announced that the Food and Drug Administration recently accepted Amneal’s 505(b)(2) New Drug Application for a newly licensed dihydroergotamine (DHE) prefilled syringe autoinjector and the company said it anticipates a decision by the middle of 2022. If approved, Amneal anticipates a commercial launch in the second half of 2022. Amneal plans to commercialize the product solely in the U.S. market.
"The addition of the DHE autoinjector reflects our commitment to expand our Specialty portfolio by bringing impactful therapies that deliver differentiated value for patients in need," said Joseph Todisco, Chief Commercial Officer for Amneal Specialty. "We plan to leverage our existing commercial infrastructure in Neurology and experience in the migraine and headache space to bring this product to market."
The proposed indication for the product is acute migraine with and without aura and cluster headache in adults. DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. Currently, DHE is also available both as ampules for injection or as a nasal spray formulation for at-home use. This product would allow patients to self-administer DHE via a single-dose, ready-to-use autoinjector pen without the need for assembly.
Over 39 million Americans are living with migraine(1), and up to one million with cluster headache.(2) Headache is the fourth most common reason for emergency department visits, and accounts for 3% of all ER visits in the United States.(3)
https://finance.yahoo.com/news/amneal-announces-dihydroergotamine-dhe-autoinjector-120000789.html
Moderna Files for Conditional Marketing Approval for COVID-19 Vaccine in Teens in EU
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted for a conditional marketing approval (CMA) for its COVID-19 vaccine in adolescents with the European Medicines Agency (EMA).
In May, the Company announced that the Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition. The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% when using the same case definition as in the Phase 3 COVE study in adults. In addition, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose using the secondary Centers for Disease Control and Prevention (CDC) case definition of COVID-19, which tested for milder disease. The study enrolled 3,732 participants ages 12 to less than 18 years in the U.S.
Translate Bio Hits Manufacturing Milestone Related to Influenza mRNA Vaccine Program
Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat or prevent debilitating or life-threatening diseases, today announced it has achieved a manufacturing milestone under the collaboration with Sanofi Pasteur related to its influenza mRNA vaccine program. Translate Bio will receive a $50 million payment from Sanofi Pasteur for the successful manufacture, release, and delivery of clinical drug product to supply Sanofi Pasteur’s Phase 1 influenza clinical trial which is anticipated to begin in the coming weeks. The Phase 1 clinical trial will evaluate a monovalent influenza vaccine candidate and will inform the next steps of the mRNA-based influenza vaccine program.
“Since beginning our collaboration in June 2018, the development of mRNA vaccines for infectious diseases, including an mRNA vaccine candidate for influenza, has been a key focus of the joint development team at Translate Bio and Sanofi Pasteur, a world leader in influenza vaccines,” said Ronald Renaud, chief executive officer, Translate Bio. “With the COVID-19 vaccine clinical program ongoing, today’s announcement is another important milestone representing the significant progress we’ve made with vaccine platform development under the collaboration as we continue to advance multiple mRNA vaccine candidates toward clinical development.”
Novartis tislelizumab met primary endpoint of overall survival in pivotal Phase III trial of esophageal cancer
Novartis announced today results from the pivotal Phase III RATIONALE 302 trial showing the investigational anti-PD-1 immune checkpoint inhibitor tislelizumab improved overall survival (OS) versus chemotherapy (median 8.6 months vs. 6.3 months, p=0.0001).1 The study evaluated tislelizumab in patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who had received prior systemic therapy. Results were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
Results from RATIONALE 302 in ESCC showed tislelizumab extended median OS by 2.3 months compared to chemotherapy with a 30% reduction in the risk of death (HR=0.70, 95% CI: 0.57-0.85, p=0.0001).1 In PD-L1 positive patients, tislelizumab extended median OS by 3.5 months with a 46% reduction in the risk of death (HR=0.54, 95% CI: 0.36-0.79, p=0.0006).1
"These data show that tislelizumab has the potential to help patients with esophageal squamous cell carcinoma – one of the deadliest types of cancers – live longer," said Jeff Legos, Ph.D., MBA, Senior Vice President and Head of Oncology Drug Development. "We are excited about these results from the newest asset in our portfolio of transformational medicines and look forward to sharing these data with regulatory authorities, as we continue to explore the full potential of this uniquely designed anti-PD-1 antibody."
Treatment with tislelizumab demonstrated median progression-free survival (PFS) of 1.6 months compared to 2.1 months (HR=0.83, 95% CI: 0.67–1.01). Tislelizumab demonstrated a higher and more durable anti-tumor activity than chemotherapy (objective response rate [ORR], 20.3% vs. 9.8%; median duration of response [DoR], 7.1 months vs. 4.0 months).1
The discontinuation rate due to treatment-related adverse events (TRAEs) was lower in patients who received tislelizumab (6.7%) compared to chemotherapy (13.8%). The most common all-grade TRAEs (≥10%) with tislelizumab were increased aspartate aminotransferase (11.4%), anemia (11%) and hypothyroidism (10.2%). No new safety signals were identified.1
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