Latest News for: Executive nda


Actinium Announces Multiple Senior Leadership Appointments Including Chief Business and Commercial Officer, New Chief Medical ...

The Salamanca Press 23 Sep 2021
Desai's execution since he joined Actinium last November ... Desai was responsible for the international development of oncology products in solid tumors and hematological malignancies at Sanofi, where he successfully executed pivotal trials that led to NDA submission for Jevtana® (cabazitaxel).

Mechanism for women's entry into NDA to be released by May 2022, Defence Ministry tells ...

Deccan Herald 21 Sep 2021
The Union government has told the Supreme Court it proposed to put in place all necessary mechanisms and infrastructure by May, next year to allow entry of women in three defence services in the existing streams through the prestigious National Defence Academy (NDA) ... Women now allowed to join NDA, Centre tells Supreme Court ... NDA.

Curriculum for women cadets at NDA in the works, exams from May, SC told

The Times of India 21 Sep 2021
The government said, a notification allowing women candidates to take the entrance exam for entry into all three defence services in the existing streams through National Defence Academy (NDA) will be released in May, 2022 ... women cadets at NDA incorporating all relevant aspects".

Wall Street billionaire Leon Black is accused of rape by a second woman who claims ...

The Daily Mail 21 Sep 2021
In that suit Ganieva accused Black of being a 'violent, sadistic,' sexual predator who raped and harassed her then coerced her into signing an NDA ... Doe', were added to a previous lawsuit filed by former model Guzel Ganieva (pictured in 2011) who accused Black of sexually assaulting her and then coercing her to sign an NDA.

EA’s share price dropped thanks to the ‘Battlefield 2042’ delay

NME 16 Sep 2021
READ MORE ... A past closed beta led to the sharing of technical playtest footage online although EA was swift to point out that breaking that particular beta NDA could lead to a ban from the full game. In other news, Amazon Games has hired Ubisoft executive, Alexandre Parizeau, to lead a “competitive multiplayer” as his first project. .

SC castigates Centre on their 'right to reject names for tribunals'

The Telegraph India 15 Sep 2021
Ramana reminded the Centre that India is a “democratic country following the rule of law” and the executive cannot “cherry-pick” names ... After the NDA government came to power in 2014, there has been constant friction between the judiciary and the executive over the appointment process of judges to the Supreme Court and the high courts.

Dermavant Announces First Patient Dosed in ADORING, its Pivotal Phase 3 Clinical Program for Tapinarof ...

The Marshall News Messenger 09 Sep 2021
alone. The start of our Phase 3 program for tapinarof in atopic dermatitis represents a significant milestone for Dermavant, and follows quickly after the FDA’s acceptance of our NDA for tapinarof for the treatment of plaque psoriasis,” Todd Zavodnick, Chief Executive Officer of Dermavant ... Brown, M.D., J.D., Chief Medical Officer of Dermavant ... SOURCE.

SB 331 to expand protections for victims of workplace harassment

Santa Barbara News-Press 02 Sep 2021
The provisions in SB 331 will provide a voice to low-wage workers in particular, who could otherwise not afford a high-power attorney to negotiate the terms of an NDA, Elsa Granados, the executive director of Santa Barbara-based Standing Together to End Sexual Assault, told the News-Press Wednesday.

The Donerail Group Responds to Turtle Beach

Omaha World-Herald 26 Aug 2021
Naturally, we understood that the process of conducting such due diligence would entail executing a non-disclosure agreement (“NDA”). Unfortunately, the Board proposed an NDA that we doubt any rational person would sign.The NDA ... The first iteration of the NDA proposed by the Board was far from “customary”.

Enterin Announces Appointment of Hilde Williams as Senior Regulatory Advisor

The Bradford Era 25 Aug 2021
Williams has successfully led regulatory strategy from Pre-IND through NDA for neurologic, psychiatric, and other development programs and has served in executive leadership team positions ... Williams successfully garnered FDA agreement for an NDA submission based on a single Phase ...

Amneal Announces Positive Topline Results from Pivotal Phase 3 RISE-PD Clinical Trial of IPX-203 in ...

The Marshall News Messenger 25 Aug 2021
Based on these topline results plus other supportive data, Amneal plans to submit a New Drug Application (NDA) for IPX-203 with the U.S ... “We look forward to submitting an NDA with the FDA and potentially making this treatment available to the PD community.”.

Stealth BioTherapeutics Strengthens IP Portfolio with Issuance of U.S. Patents Covering Elamipretide for Barth Syndrome

Daily Times Chronicle 23 Aug 2021
"This expansion of the breadth and depth of our intellectual property portfolio further demonstrates our commitment to developing elamipretide for the treatment of Barth syndrome," said Chief Executive Officer Reenie McCarthy. "We look forward to working with the FDA as it evaluates our August NDA submission.

BioLineRx Reports Second Quarter 2021 Financial Results and Provides Corporate Update

The Salamanca Press 18 Aug 2021
"Following the overwhelmingly positive results from our Phase 3 GENESIS trial of Motixafortide in stem-cell mobilization that we announced in May, we are working vigorously to submit an NDA in the first half of next year," stated Philip Serlin, Chief Executive Officer of BioLineRx.

Iterum Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update

Tyler Morning Telegraph 13 Aug 2021
... Type A meeting with the FDA expected later this quarter and we hope to receive adequate guidance and agreement with the FDA on a path forward that will lead to resubmission of our New Drug Application (“NDA”) as quickly as possible,” said Corey Fishman, Chief Executive Officer.

Forma Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update

The Marshall News Messenger 13 Aug 2021
... and the timing associated with the initiation or continuation of any trials and success of ongoing clinical trials of etavopivat and FT-7051; Forma’s ability to execute on its strategy; the submission and acceptance of a new drug application (NDA) for submission to the U.S.

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