On October 11, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that it will present early clinical data for repotrectinib from the ongoing Phase 1/2 CARE study in pediatric and young adult patients with advanced solid tumors harboring ALK, ROS1 or NTRK alterations at the virtual 53rd Congress of the International Society of Paediatric Oncology (SIOP) being held October 21-24 (Press release, Turning Point Therapeutics, OCT 11, 2021, View Source [SID1234591109]).

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Details for the Presentation
Presentation Title: A Phase 1/2, open-label study of repotrectinib in pediatric and young adult patients with advanced or metastatic malignancies harboring ALK, ROS1, or NTRK1-3 alterations
Session Name: 910 – FPS 04-Live Q&A-New Drugs/Experimental Therapeutics
Session Type: Free Paper Session (FPS)
Date / Session Time: Saturday, October 23, 2021, 8:40 – 9:40 a.m. ET
Lecture Time: 9:12 – 9:22 a.m. ET
Presenter: Steven G. Dubois, M.D., Associate Professor of Pediatrics, Harvard Medical School, Director, Experimental Therapeutics for Pediatric Oncology, Dana-Farber Cancer Institute

The presentation from SIOP 2021 will be available on the company’s website shortly after the event at www.tptherapeutics.com.

On October 11, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, OCT 11, 2021, View Source [SID1234591104]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 4 August 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021.

Since the announcement 4 October 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 21,365,947 B shares of DKK 0.20 as treasury shares, corresponding to 0.9% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 8 October 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 22,558,781 B shares at an average share price of DKK 502.84 per B share equal to a transaction value of DKK 11,343,423,385.

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 45,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

On October 11, 2021 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") reported that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on the Company’s rusfertide clinical studies, announced on September 17, 2021 (Press release, Protagonist, OCT 11, 2021, View Source [SID1234591098]). Per the FDA, dosing in all clinical studies of rusfertide may be resumed.

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The Company provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold. In particular, the Company provided the requested individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, performed a comprehensive review of the most recent safety database, and included new safety and stopping rules in the study protocols. The Company is working closely with study investigators and clinical trial sites to resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.

The clinical hold was initially triggered by a recent non-clinical finding in a 26-week rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors. The rasH2 signal also prompted a re-examination of the four cases of cancer observed across all rusfertide clinical trials involving over 160 patients, and a comprehensive review of the safety database, including cases of suspected unexpected serious adverse reactions (SUSAR). No additional cancer cases, and no other unexpected safety signals, surfaced in this process.

"We are extremely pleased that the FDA has acted so quickly in lifting the clinical hold on the rusfertide development program, allowing us to resume patient dosing in our clinical studies," said Dinesh Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Patient safety continues to be our topmost priority. We believe that the cumulative evidence regarding the safety and clinical risk-benefit of rusfertide is supportive of expedited clinical development. We are actively preparing to initiate the phase 3 registrational study for polycythemia vera in the first quarter of 2022. Protagonist will continue to work closely with the FDA to ensure patient safety with amendments to current and planned future studies with rusfertide. We remain optimistic about the future potential of rusfertide to address unmet medical needs in excessive erythrocytosis and iron overload related diseases like polycythemia vera and hereditary hemochromatosis, respectively."

Conference Call and Webcast Information

A conference call will take place today, October 11, 2021, at 8:00 a.m. ET.

Live audio of the conference call will be simultaneously broadcast over the internet. The call will be available to investors, members of the news media, and the general public.

To access the live call, dial (877) 870-4263 (U.S./Canada) or (412) 317-0790 (international) five minutes prior to the call and ask to be joined to the Protagonist Therapeutics call. A live and archived webcast will be accessible in the Investors section of the Company’s website at www.protagonist-inc.com.

On October 11, 2021 GSK reported proposals for a major new UK-based headquarters and global campus for the new Consumer Healthcare company following separation in 2022, and its long-term plan for the future headquarters of GSK (Press release, GlaxoSmithKline, OCT 11, 2021, View Source [SID1234591097]).

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New Consumer Healthcare company headquarters to be based in Weybridge, UK
The proposals announced today form part of GSK’s ongoing work to prepare for the separation of the Group into two leading UK-based companies next year – new GSK, a global pharmaceuticals and vaccines company with an R&D approach focused on the science of the immune system, human genetics and advanced technologies, and a world leading Consumer Healthcare company with annual sales of more than £10 billion, including nine global power brands holding category leadership positions.

Under the proposals announced today the new Consumer Healthcare company will build a new campus in Weybridge, UK. This campus will house the global headquarters for the new Consumer Healthcare business, including an innovation centre (made up of R&D laboratories and the Consumer Healthcare Shopper Science lab) and the company’s global support function teams based in the UK. It will be home to around 1,400 employees.

The new Consumer Healthcare company will open its new headquarters at the end of 2024, subject to consultation and planning approvals. Whilst the development of the campus is ongoing, and at the point of separation of the two companies – expected in mid-2022 – Consumer Healthcare teams will leave GSK House in Brentford and will move to a temporary headquarters in Weybridge, at a site close to but separate from the company’s existing facilities in the area.

Brian McNamara, CEO Designate, GSK Consumer Healthcare said: "This investment in a new cutting-edge campus in the UK will bring together our first-in-class teams as we drive towards our ambitions as the world’s leading consumer healthcare company. Today’s announcement is an important step as we prepare for separation, marking an exciting new beginning for New Consumer Healthcare."

GSK to move to new UK headquarters after separation
Following separation, GSK will move to a new UK headquarters. The company will identify an appropriate site that meets the needs of the new organisation, with the search based in the same area as GSK’s current headquarters, maintaining access to the UK’s world-leading science and innovation hubs; GSK will provide a further update on its new headquarters in mid-2022, and expects to remain at the company’s current headquarters, at GSK House in Brentford, until at least the end of 2023.

On October 11, 2021 Outcomes4Me Inc., developer of a leading free mobile app and platform to navigate cancer treatment and care, reported that it has partnered with Invitae Corporation (NYSE: NVTA), a leading medical genetics company, to expand education and access to genetic testing to breast cancer patients and survivors (Press release, Invitae, OCT 11, 2021, View Source [SID1234591089]). The collaboration leverages the strengths of Invitae, which supplies clinical grade genetic testing, and Outcomes4Me’s 360-degree, validated and evidence-based cancer support and treatment options via its free and easy-to-use app. Initially and currently available in the United States, patients can now receive genetic counseling through Invitae’s partnership with Genome Medical, get testing, and upload their results within the Outcomes4Me app.

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There is a misconception that genetic testing is only useful as a preventative tool prior to a cancer diagnosis. According to Outcomes4Me patient data, almost half of users (46 percent) who qualified for testing (based on NCCN Guidelines) did not receive testing or did not know if they had received testing. However, genetic testing can provide insights that can help inform and refine precision therapy use and clinical treatment trial enrollment. In addition, genetic testing results can be used to help prevent recurrence and reduce incidence of other inherited cancers.

A cancer diagnosis is often overwhelming for patients and their families. Outcomes4Me demystifies cancer by providing the most up-to-date and validated research, support, and treatment options, all grounded in science and data and curated according to the patient’s specific diagnosis. Outcomes4Me partners with the researchers, doctors, and academics that set the rigorous standards of cancer care for all treatment providers, including the National Comprehensive Care Network (NCCN), Vanderbilt-Ingram Cancer Center (VICC) and Massachusetts General Hospital (MGH). The collaboration with Invitae expands access to genetic testing, a vitally important tool in the patient’s cancer care arsenal.

"Outcomes4Me is an indispensable platform for patients with breast cancer, giving them the personalized knowledge and access to timely new trials and targeted therapies that could lead to better health outcomes," said Ed Esplin, M.D., Ph.D., FACMG, FACP, Clinical Geneticist at Invitae. "By providing access to our comprehensive genetic testing and counseling services, Outcomes4Me is adding a valuable resource that will empower patients to advance their knowledge, understanding, and therefore, self-advocacy during treatment and survivorship."

Unlike popular direct-to-consumer genetic testing services, which test for a few specific genetic variants for certain genes, Invitae provides state-of-the-art clinical grade next-generation sequencing-based (NGS) genetic testing that comprehensively analyses more than 80 genes, including all known mutations of the important BRCA1/BRCA2 genes. This comprehensive approach, combined with associated genetic counseling, not only provides insights for cancer patients, but also for family members who may be at risk.

"Our collaboration with Invitae reinforces Outcomes4Me’s mission to give patients back control," said Maya R. Said, Sc. D., Founder and CEO of Outcomes4Me. "Because of this work with Invitae, our valued community now has rare direct access to a much-needed testing service. Outcomes4Me will proudly continue to democratize the best in cancer treatment, research, and support by removing barriers and bias in information flow."